An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer (FAR-122)

• ClinicalTrials.gov Identifier: NCT00738699
• Recruitment Status: Terminated
• First Posted: August 20, 2008
• Results First Posted: March 30, 2017
• Last Update Posted: March 30, 2017
• Sponsor: Morphotek
• Information provided by (Responsible Party): Morphotek

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Ovarian Cancer
• Interventions: Drug: MORAb-003 (farletuzumab); Drug: 0.9% Saline; Drug: Paclitaxel
• Enrollment: 415

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
Arm/Group Description	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Period Title: Overall Study
Started	275	140
Participants Not Treated	2	1
Participants Treated	273	139
Completed	0	0
Not Completed	275	140
Reason Not Completed
Withdrawal by Subject	5	0
Lost to Follow-up	1	0
Death	144	68
Discontinuation of study by Sponsor	123	72
Other	2	0

Baseline Characteristics

Arm/Group Title		MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel	Total
Arm/Group Description		Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	Total of all reporting groups
Overall Number of Baseline Participants		275	140	415
Baseline Analysis Population Description		Intent-to-Treat population included, the primary population for the evaluation of efficacy, was defined as all participant who were randomly assigned to test article, analyzed by the treatment assigned.
Age, Continuous; Geometric Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	275 participants	140 participants	415 participants
		60.9 (10.74)	61.2 (9.44)	61.0 (10.31)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	275 participants	140 participants	415 participants
	Female	275 100.0%	140 100.0%	415 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Progression-Free Survival (PFS)
Description	PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
Time Frame	Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) population included all participants who were randomly assigned to study drug, analyzed by treatment assignment.

Arm/Group Title	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
Arm/Group Description:	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed	275	140
Median (95% Confidence Interval); Unit of Measure: Months
	3.5; (3.3 to 3.9)	3.7; (3.3 to 5.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MORAb-003 (Farletuzumab) Plus Paclitaxel, Placebo (Normal Saline) Plus Paclitaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8360
	Comments	One-sided log rank test stratified by route of administration for primary chemotherapy (intraperitoneal vs intravenous) and geographic region (North America, Europe, and other participating countries).
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.46
	Estimation Comments	Stratified as described above.

2. Primary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.
Time Frame	Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.

Arm/Group Title	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
Arm/Group Description:	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed	275	140
Median (95% Confidence Interval); Unit of Measure: Months
	11.3; (10.3 to 12.7)	13.1; (10.3 to 16.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MORAb-003 (Farletuzumab) Plus Paclitaxel, Placebo (Normal Saline) Plus Paclitaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7568
	Comments	One-sided log rank test stratified by route of administration for primary chemotherapy and geographic region.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.48
	Estimation Comments	Stratified as described above

3. Secondary Outcome

Title	Best Overall Response
Description	BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).
Time Frame	Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.

Arm/Group Title	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
Arm/Group Description:	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed	275	140
Measure Type: Number; Unit of Measure: Percentage of participants
Complete response (CR)	0.4	0
Partial response (PR)	7.3	15.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MORAb-003 (Farletuzumab) Plus Paclitaxel, Placebo (Normal Saline) Plus Paclitaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0399
	Comments	Compared the ratio of complete or partial responders in the two arms. Stratified by route of administration for first line therapy and geographic region as specified at baseline.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-7.4
	Confidence Interval	(2-Sided) 95%; -14.1 to -0.7
	Estimation Comments	(FAR + Paclitaxel) minus (Placebo + Paclitaxel). Confidence interval based on a normal approximation to the binomial distribution.

4. Secondary Outcome

Title	Time to Tumor Response (TTR)
Description	TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.
Time Frame	Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months

Outcome Measure Data

Analysis Population Description

ITT population (Responders only) included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.

Arm/Group Title	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
Arm/Group Description:	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed	21	21
Median (95% Confidence Interval); Unit of Measure: Months
	2.0; (1.6 to 3.5)	1.7; (1.6 to 3.3)

5. Other Pre-specified Outcome

Title	Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)
Description	Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.
Time Frame	Length of study

Outcome Measure Data

Analysis Population Description

Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.

Arm/Group Title	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
Arm/Group Description:	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

6. Other Pre-specified Outcome

Title	Serologic Response Rate
Description	Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.
Time Frame	Length of study

Outcome Measure Data

Analysis Population Description

Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.

Arm/Group Title	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
Arm/Group Description:	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Adverse Event Reporting Description	Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
Arm/Group Title	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
Arm/Group Description	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
All-Cause Mortality
	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
	Affected / at Risk (%)	Affected / at Risk (%)
Total	127/279 (45.52%)	55/133 (41.35%)
Blood and lymphatic system disorders
Anaemia * 1	7/279 (2.51%)	7/133 (5.26%)
Neutropenia † 2	6/279 (2.15%)	1/133 (0.75%)
Febrile Neutropenia † 2	4/279 (1.43%)	1/133 (0.75%)
Leukopenia † 2	2/279 (0.72%)	0/133 (0.00%)
Cardiac disorders
Atrial Fibrillation † 2	2/279 (0.72%)	1/133 (0.75%)
Cardiac Failure Congestive † 2	1/279 (0.36%)	0/133 (0.00%)
Cardio-Respiratory Arrest † 2	1/279 (0.36%)	0/133 (0.00%)
Gastrointestinal disorders
Small Intestinal Obstruction † 2	18/279 (6.45%)	7/133 (5.26%)
Intestinal Obstruction † 2	10/279 (3.58%)	4/133 (3.01%)
Vomiting † 2	9/279 (3.23%)	5/133 (3.76%)
Constipation † 2	9/279 (3.23%)	2/133 (1.50%)
Ascites † 2	8/279 (2.87%)	2/133 (1.50%)
Nausea † 2	5/279 (1.79%)	3/133 (2.26%)
Abdominal Pain † 2	5/279 (1.79%)	1/133 (0.75%)
Diarrhoea † 2	2/279 (0.72%)	3/133 (2.26%)
Colonic Obstruction † 2	3/279 (1.08%)	0/133 (0.00%)
Ileus † 2	2/279 (0.72%)	1/133 (0.75%)
Gastrointestinal Haemorrhage † 2	2/279 (0.72%)	0/133 (0.00%)
Gastrointestinal Obstruction † 2	1/279 (0.36%)	1/133 (0.75%)
Intestinal Perforation † 2	2/279 (0.72%)	0/133 (0.00%)
Large Intestinal Obstruction † 2	1/279 (0.36%)	1/133 (0.75%)
Large Intestine Perforation † 2	1/279 (0.36%)	1/133 (0.75%)
Abdominal adhesions † 2	1/279 (0.36%)	0/133 (0.00%)
Colonic Pseudo-obstruction † 2	1/279 (0.36%)	0/133 (0.00%)
Diverticulum † 2	1/279 (0.36%)	0/133 (0.00%)
Enterocutaneous Fistula † 2	1/279 (0.36%)	0/133 (0.00%)
Faecal Volume Decreased † 2	1/279 (0.36%)	0/133 (0.00%)
Faecal Volume Increased † 2	1/279 (0.36%)	0/133 (0.00%)
Gastric Ulcer † 2	1/279 (0.36%)	0/133 (0.00%)
Gastrointestinal Inflammation † 2	1/279 (0.36%)	0/133 (0.00%)
Gastrointestinal Perforation † 2	1/279 (0.36%)	0/133 (0.00%)
Oesophageal Obstruction † 2	1/279 (0.36%)	0/133 (0.00%)
Rectourethral Fistula † 2	1/279 (0.36%)	0/133 (0.00%)
Short-Bowel Syndrome † 2	1/279 (0.36%)	0/133 (0.00%)
General disorders
Disease Progression † 2	17/279 (6.09%)	7/133 (5.26%)
Pyrexia † 2	15/279 (5.38%)	2/133 (1.50%)
Fatigue † 2	3/279 (1.08%)	1/133 (0.75%)
Asthenia † 2	1/279 (0.36%)	1/133 (0.75%)
Obstruction † 2	1/279 (0.36%)	1/133 (0.75%)
Pain † 2	1/279 (0.36%)	1/133 (0.75%)
Generalised Oedema * 1	1/279 (0.36%)	0/133 (0.00%)
Hernia Obstructive † 2	1/279 (0.36%)	0/133 (0.00%)
Oedema Peripheral † 2	1/279 (0.36%)	0/133 (0.00%)
Hepatobiliary disorders
Cholecystitis Acute * 1	1/279 (0.36%)	1/133 (0.75%)
Cholangitis † 2	1/279 (0.36%)	0/133 (0.00%)
Infections and infestations
Cellulitis * 1	6/279 (2.15%)	2/133 (1.50%)
Urinary Tract Infection † 2	5/279 (1.79%)	3/133 (2.26%)
Pneumonia † 2	4/279 (1.43%)	2/133 (1.50%)
Sepsis † 2	3/279 (1.08%)	1/133 (0.75%)
Catheter Site Infection † 2	1/279 (0.36%)	1/133 (0.75%)
Device Related Infection † 2	1/279 (0.36%)	1/133 (0.75%)
Infection † 2	1/279 (0.36%)	1/133 (0.75%)
Lobar Pneumonia † 2	1/279 (0.36%)	1/133 (0.75%)
Abdominal Infection † 2	0/279 (0.00%)	1/133 (0.75%)
Bacterial Pyelonephritis † 2	1/279 (0.36%)	0/133 (0.00%)
Candida Sepsis * 1	1/279 (0.36%)	0/133 (0.00%)
Clostridium Difficle Colitis † 2	1/279 (0.36%)	0/133 (0.00%)
Escherichia Sepsis † 2	0/279 (0.00%)	1/133 (0.75%)
Herpes Zoster † 2	1/279 (0.36%)	0/133 (0.00%)
Incision Site Infection † 2	0/279 (0.00%)	1/133 (0.75%)
Infectious Peritonitis † 2	0/279 (0.00%)	1/133 (0.75%)
Klebsiella Bacteraemia † 2	0/279 (0.00%)	1/133 (0.75%)
Meningitis † 2	0/279 (0.00%)	1/133 (0.75%)
Parotitis † 2	1/279 (0.36%)	0/133 (0.00%)
Pelvic Infection † 2	1/279 (0.36%)	0/133 (0.00%)
Postoperative Wound Infection † 2	1/279 (0.36%)	0/133 (0.00%)
Pseudomonal Sepsis † 2	1/279 (0.36%)	0/133 (0.00%)
Respiratory Tract Infection * 1	1/279 (0.36%)	0/133 (0.00%)
Retroperitoneal Abcess † 2	1/279 (0.36%)	0/133 (0.00%)
Urosepsis † 2	1/279 (0.36%)	0/133 (0.00%)
Pneumonia bacterial * 1	1/279 (0.36%)	0/133 (0.00%)
Injury, poisoning and procedural complications
Postoperative Ileus † 2	0/279 (0.00%)	1/133 (0.75%)
Tibia fracture † 2	1/279 (0.36%)	0/133 (0.00%)
Investigations
Haemoglobin Decreased † 2	0/279 (0.00%)	1/133 (0.75%)
Weight decreased † 2	1/279 (0.36%)	0/133 (0.00%)
Metabolism and nutrition disorders
Dehydration † 2	4/279 (1.43%)	0/133 (0.00%)
Decreased Appetite † 2	1/279 (0.36%)	0/133 (0.00%)
Failure to thrive † 2	1/279 (0.36%)	0/133 (0.00%)
Hypocalcaemia † 2	1/279 (0.36%)	0/133 (0.00%)
Hypokalaemia † 2	1/279 (0.36%)	0/133 (0.00%)
Hypomagnesaemia * 1	1/279 (0.36%)	0/133 (0.00%)
Hyponatraemia † 2	1/279 (0.36%)	0/133 (0.00%)
Hypophagia * 1	1/279 (0.36%)	0/133 (0.00%)
Malnutrition † 2	1/279 (0.36%)	0/133 (0.00%)
Musculoskeletal and connective tissue disorders
Back Pain † 2	2/279 (0.72%)	1/133 (0.75%)
Fistula † 2	1/279 (0.36%)	0/133 (0.00%)
Muscle Necrosis † 2	0/279 (0.00%)	1/133 (0.75%)
Muscular Weakness † 2	1/279 (0.36%)	0/133 (0.00%)
Musculoskeletal Chest Pain † 2	0/279 (0.00%)	1/133 (0.75%)
Myalgia † 2	1/279 (0.36%)	0/133 (0.00%)
Pain in Extremity † 2	1/279 (0.36%)	0/133 (0.00%)
Systemic Lupus Erythematosus † 2	0/279 (0.00%)	1/133 (0.75%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic Complication * 1	3/279 (1.08%)	0/133 (0.00%)
Metastases to Central Nervous System † 2	0/279 (0.00%)	2/133 (1.50%)
Colon Cancer † 2	1/279 (0.36%)	0/133 (0.00%)
Metastatic Neoplasm † 2	1/279 (0.36%)	0/133 (0.00%)
Tumour Associated Fever † 2	1/279 (0.36%)	0/133 (0.00%)
Nervous system disorders
Syncope † 2	2/279 (0.72%)	1/133 (0.75%)
Brain Mass † 2	1/279 (0.36%)	0/133 (0.00%)
Convulsion † 2	1/279 (0.36%)	0/133 (0.00%)
Encephelopathy † 2	0/279 (0.00%)	1/133 (0.75%)
Lethargy † 2	1/279 (0.36%)	0/133 (0.00%)
Mononeuritis † 2	0/279 (0.00%)	1/133 (0.75%)
Neuropathy Peripheral † 2	1/279 (0.36%)	0/133 (0.00%)
Posterior Reversible Encephelopathy Syndrome † 2	1/279 (0.36%)	0/133 (0.00%)
Psychiatric disorders
Depression * 1	2/279 (0.72%)	1/133 (0.75%)
Anxiety † 2	1/279 (0.36%)	0/133 (0.00%)
Disorientation † 2	1/279 (0.36%)	0/133 (0.00%)
Mental Status Change † 2	1/279 (0.36%)	0/133 (0.00%)
Renal and urinary disorders
Renal Failure Acute † 2	2/279 (0.72%)	2/133 (1.50%)
Hydronephrosis † 2	2/279 (0.72%)	1/133 (0.75%)
Renal Failure † 2	1/279 (0.36%)	2/133 (1.50%)
Bladder Spasm † 2	1/279 (0.36%)	0/133 (0.00%)
Dysuria † 2	1/279 (0.36%)	0/133 (0.00%)
Renal Impairment † 2	0/279 (0.00%)	1/133 (0.75%)
Ureteric Obstruction † 2	1/279 (0.36%)	0/133 (0.00%)
Urinary Tract Obstruction † 2	1/279 (0.36%)	0/133 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism * 1	10/279 (3.58%)	4/133 (3.01%)
Dyspnoea † 2	7/279 (2.51%)	4/133 (3.01%)
Pleural Effusion † 2	3/279 (1.08%)	2/133 (1.50%)
Pneumonitis * 1	5/279 (1.79%)	0/133 (0.00%)
Epistaxis † 2	1/279 (0.36%)	0/133 (0.00%)
Interstitial Lung Disease † 2	1/279 (0.36%)	0/133 (0.00%)
Respiratory Failure † 2	1/279 (0.36%)	0/133 (0.00%)
Tachypnoea † 2	0/279 (0.00%)	1/133 (0.75%)
Skin and subcutaneous tissue disorders
Dermatits Exfoliative † 2	0/279 (0.00%)	1/133 (0.75%)
Palmar-Plantar Erythrodysaesthesia Syndrome † 2	1/279 (0.36%)	0/133 (0.00%)
Rash † 2	1/279 (0.36%)	0/133 (0.00%)
Skin Toxicity † 2	1/279 (0.36%)	0/133 (0.00%)
Vascular disorders
Hypotension † 2	2/279 (0.72%)	2/133 (1.50%)
Thrombosis † 2	3/279 (1.08%)	0/133 (0.00%)
Deep Vein Thrombosis † 2	1/279 (0.36%)	1/133 (0.75%)
Subclavian Vein Thrombosis † 2	1/279 (0.36%)	0/133 (0.00%)
Superior Vena Cava Syndrome † 2	0/279 (0.00%)	1/133 (0.75%)
Venous Thrombosis Limb † 2	1/279 (0.36%)	0/133 (0.00%)
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDra 14.1; 2 Term from vocabulary, Select
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	MORAb-003 (Farletuzumab) Plus Paclitaxel	Placebo (Normal Saline) Plus Paclitaxel
	Affected / at Risk (%)	Affected / at Risk (%)
Total	278/279 (99.64%)	133/133 (100.00%)
Blood and lymphatic system disorders
Anaemia † 2	78/279 (27.96%)	37/133 (27.82%)
Neutropenia † 2	38/279 (13.62%)	18/133 (13.53%)
Leukopenia † 2	16/279 (5.73%)	9/133 (6.77%)
Eye disorders
Vision Blurred † 2	14/279 (5.02%)	8/133 (6.02%)
Gastrointestinal disorders
Nausea * 1	132/279 (47.31%)	66/133 (49.62%)
Diarrhoea † 2	119/279 (42.65%)	53/133 (39.85%)
Constipation † 2	96/279 (34.41%)	53/133 (39.85%)
Abdominal pain † 2	88/279 (31.54%)	34/133 (25.56%)
Vomiting † 2	84/279 (30.11%)	37/133 (27.82%)
Abdominal Distension † 2	51/279 (18.28%)	21/133 (15.79%)
Ascites † 2	22/279 (7.89%)	11/133 (8.27%)
Stomatitis † 2	26/279 (9.32%)	7/133 (5.26%)
Dyspepsia † 2	22/279 (7.89%)	10/133 (7.52%)
Abdominal Pain Upper † 2	25/279 (8.96%)	6/133 (4.51%)
Dry mouth † 2	19/279 (6.81%)	8/133 (6.02%)
Small intestinal Obstruction † 2	19/279 (6.81%)	7/133 (5.26%)
Flatulence † 2	18/279 (6.45%)	5/133 (3.76%)
Gastroresophageal Reflux Disease † 2	10/279 (3.58%)	8/133 (6.02%)
General disorders
Fatigue † 2	184/279 (65.95%)	82/133 (61.65%)
Oedema Peripheral † 2	60/279 (21.51%)	26/133 (19.55%)
Pyrexia † 2	43/279 (15.41%)	18/133 (13.53%)
Asthenia † 2	24/279 (8.60%)	12/133 (9.02%)
Mucosal Inflammation † 2	24/279 (8.60%)	11/133 (8.27%)
Chills † 2	18/279 (6.45%)	7/133 (5.26%)
Disease Progression † 2	17/279 (6.09%)	7/133 (5.26%)
Pain † 2	17/279 (6.09%)	7/133 (5.26%)
Oedema † 2	6/279 (2.15%)	7/133 (5.26%)
Infections and infestations
Urinary Tract Infection † 2	47/279 (16.85%)	30/133 (22.56%)
Upper Respiratory Tract Infection † 2	24/279 (8.60%)	6/133 (4.51%)
Nasopharyngitits † 2	16/279 (5.73%)	4/133 (3.01%)
Sinusitis † 2	10/279 (3.58%)	9/133 (6.77%)
Injury, poisoning and procedural complications
Contusion † 2	19/279 (6.81%)	1/133 (0.75%)
Metabolism and nutrition disorders
Decreased Appetite † 2	67/279 (24.01%)	27/133 (20.30%)
Hypomagnesaemia † 2	31/279 (11.11%)	18/133 (13.53%)
Hypokalaemia † 2	28/279 (10.04%)	9/133 (6.77%)
Dehydration † 2	14/279 (5.02%)	5/133 (3.76%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	43/279 (15.41%)	22/133 (16.54%)
Back Pain † 2	36/279 (12.90%)	26/133 (19.55%)
Myalgia † 2	28/279 (10.04%)	17/133 (12.78%)
Pain In Extremity † 2	31/279 (11.11%)	12/133 (9.02%)
Muscle Spasms † 2	14/279 (5.02%)	12/133 (9.02%)
Musculoskeletal Pain † 2	15/279 (5.38%)	6/133 (4.51%)
Musculoskeletal Chest Pain † 2	14/279 (5.02%)	6/133 (4.51%)
Nervous system disorders
Neuropathy Peripheral * 1	75/279 (26.88%)	37/133 (27.82%)
Headache † 2	72/279 (25.81%)	28/133 (21.05%)
Dizziness † 2	42/279 (15.05%)	18/133 (13.53%)
Peripheral Sensory Neuropathy † 2	38/279 (13.62%)	15/133 (11.28%)
Dysguesia † 2	29/279 (10.39%)	22/133 (16.54%)
Restless Legs Syndrome † 2	14/279 (5.02%)	2/133 (1.50%)
Hypoaesthesia † 2	6/279 (2.15%)	7/133 (5.26%)
Psychiatric disorders
Insomnia † 2	54/279 (19.35%)	23/133 (17.29%)
Anxiety † 2	25/279 (8.96%)	16/133 (12.03%)
Depression † 2	24/279 (8.60%)	8/133 (6.02%)
Renal and urinary disorders
Dysuria † 2	9/279 (3.23%)	12/133 (9.02%)
Pollakiuria † 2	7/279 (2.51%)	9/133 (6.77%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	58/279 (20.79%)	27/133 (20.30%)
Dyspnoea † 2	56/279 (20.07%)	21/133 (15.79%)
Epistaxis † 2	50/279 (17.92%)	25/133 (18.80%)
Dyspnoea Exertional † 2	29/279 (10.39%)	6/133 (4.51%)
Oropharyngeal Pain † 2	16/279 (5.73%)	13/133 (9.77%)
Nasal Congestion † 2	9/279 (3.23%)	9/133 (6.77%)
Skin and subcutaneous tissue disorders
Alopecia * 1	143/279 (51.25%)	59/133 (44.36%)
Rash † 2	55/279 (19.71%)	19/133 (14.29%)
Nail disorder † 2	47/279 (16.85%)	19/133 (14.29%)
Dry skin † 2	18/279 (6.45%)	7/133 (5.26%)
Erythema † 2	18/279 (6.45%)	6/133 (4.51%)
Pruritus † 2	15/279 (5.38%)	8/133 (6.02%)
Hyperhidrosis † 2	13/279 (4.66%)	7/133 (5.26%)
Nail discolouration † 2	11/279 (3.94%)	7/133 (5.26%)
Vascular disorders
Flushing † 2	28/279 (10.04%)	9/133 (6.77%)
Hypotension † 2	10/279 (3.58%)	7/133 (5.26%)
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDra 14.1; 2 Term from vocabulary, Select

Limitations and Caveats

This study was prematurely terminated by the sponsor following results of the preplanned futility analysis showing the study was unlikely to meet its statistically-defined coprimary endpoints.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

 

Results Point of Contact

• Name/Title: Eisai Medical Services
• Organization: Eisai Inc.
• Phone: 1-888-422-4743

• Responsible Party: Morphotek
• ClinicalTrials.gov Identifier: NCT00738699
• Other Study ID Numbers: MORAb003-003PR
• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Results First Submitted: December 13, 2016
• Results First Posted: March 30, 2017
• Last Update Posted: March 30, 2017