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Study of Pazopanib and Doxil in Patients With Advanced Relapsed Platinum-Sensitive or Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01035658
Recruitment Status : Terminated (Based on analyses in Phase I, the study did not advance to Phase II.)
First Posted : December 21, 2009
Results First Posted : May 21, 2015
Last Update Posted : April 11, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Carcinoma
Interventions Drug: Pazopanib
Drug: Doxil
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential
Hide Arm/Group Description

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Period Title: Overall Study
Started 5 8 3 6
Completed 5 8 3 6
Not Completed 0 0 0 0
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential Total
Hide Arm/Group Description

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Total of all reporting groups
Overall Number of Baseline Participants 5 8 3 6 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 8 participants 3 participants 6 participants 22 participants
62
(51 to 69)
74
(31 to 90)
64
(51 to 64)
57
(49 to 79)
64
(31 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 8 participants 3 participants 6 participants 22 participants
Female
5
 100.0%
8
 100.0%
3
 100.0%
6
 100.0%
22
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 8 participants 3 participants 6 participants 22 participants
5 8 3 6 22
1.Primary Outcome
Title Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin
Hide Description The MTD of the drug combination will be determined as the highest dose at which ≤1 of 6 subjects experiences a Grade 3 or Grade 4 DLT according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1
Hide Arm/Group Description:
All patients in Phase I (this section contains the Maximum Tolerated Dose)
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: mg
Pazopanib 400
Liposomal doxorubicin 30
2.Primary Outcome
Title Phase II: Progression Free Survival
Hide Description Defined as from date of randomization until objective tumor progression or death.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential
Hide Arm/Group Description:

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Phase I - Dose Limiting Toxicites
Hide Description As requested, this outcome measure reports the number of patients experiencing dose limiting toxicites (DLTs) in the Phase I portion of the study
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential
Hide Arm/Group Description:

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Overall Number of Participants Analyzed 5 8 6 6
Measure Type: Number
Unit of Measure: participants
3 1 0 0
4.Secondary Outcome
Title To Determine the Overall Survival of Patients With Relapsed/Refractory Ovarian Cancer Following Treatment With Pazopanib and Liposomal Doxorubicin.
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential
Hide Arm/Group Description:

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title To Determine the Efficacy of Pazopanib/Liposomal Doxorubicin (Response Rate, Progression-free Survival, Overall Survival) Separately in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title To Evaluate the Toxicity of the Combination of Pazopanib and Liposomal Doxorubicin
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential
Hide Arm/Group Description:

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential
Hide Arm/Group Description

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

All-Cause Mortality
Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/5 (60.00%)   1/8 (12.50%)   2/3 (66.67%)   1/6 (16.67%) 
Cardiac disorders         
Atrial Fibrillation  1  0/5 (0.00%)  0/8 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  1/5 (20.00%)  0/8 (0.00%)  0/3 (0.00%)  0/6 (0.00%) 
Pancreatitis  1  1/5 (20.00%)  0/8 (0.00%)  0/3 (0.00%)  0/6 (0.00%) 
General disorders         
General disorders and administration site conditions - Other, disease progression  1  0/5 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/6 (0.00%) 
Infections and infestations         
Urinary tract infection  1  0/5 (0.00%)  1/8 (12.50%)  0/3 (0.00%)  0/6 (0.00%) 
Infections and infestations - Other, pneumonia  1  0/5 (0.00%)  0/8 (0.00%)  2/3 (66.67%)  0/6 (0.00%) 
Injury, poisoning and procedural complications         
Fracture  1  0/5 (0.00%)  0/8 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Investigations         
Alanine aminotransferase increased  1  1/5 (20.00%)  0/8 (0.00%)  0/3 (0.00%)  0/6 (0.00%) 
Aspartate aminotransferase increased  1  1/5 (20.00%)  0/8 (0.00%)  0/3 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  1/5 (20.00%)  1/8 (12.50%)  0/3 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders         
Generalized muscle weakness  1  1/5 (20.00%)  0/8 (0.00%)  0/3 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory, thoracic and mediastinal disorders - Other, COPD exacerbation  1  0/5 (0.00%)  0/8 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose Level 1 Dose Level -1 Dose Level 1 Sequential Dose Level 2 Sequential
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   8/8 (100.00%)   3/3 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders         
Anemia  1  3/5 (60.00%)  2/8 (25.00%)  1/3 (33.33%)  3/6 (50.00%) 
Gastrointestinal disorders         
Nausea  1  4/5 (80.00%)  3/8 (37.50%)  3/3 (100.00%)  2/6 (33.33%) 
Diarrhea  1  2/5 (40.00%)  3/8 (37.50%)  1/3 (33.33%)  2/6 (33.33%) 
Mucositis  1  3/5 (60.00%)  2/8 (25.00%)  0/3 (0.00%)  3/6 (50.00%) 
Vomiting  1  1/5 (20.00%)  1/8 (12.50%)  2/3 (66.67%)  1/6 (16.67%) 
General disorders         
Fatigue  1  3/5 (60.00%)  4/8 (50.00%)  3/3 (100.00%)  3/6 (50.00%) 
General disorders and administration site conditions - Other, hemorrhage  1  0/5 (0.00%)  1/8 (12.50%)  1/3 (33.33%)  1/6 (16.67%) 
Investigations         
White blood cell decreased  1  2/5 (40.00%)  5/8 (62.50%)  1/3 (33.33%)  2/6 (33.33%) 
Neutrophil count decreased  1  1/5 (20.00%)  3/8 (37.50%)  1/3 (33.33%)  3/6 (50.00%) 
Platelet count decreased  1  0/5 (0.00%)  3/8 (37.50%)  1/3 (33.33%)  2/6 (33.33%) 
Aspartate aminotransferase increased  1  1/5 (20.00%)  0/8 (0.00%)  1/3 (33.33%)  1/6 (16.67%) 
Metabolism and nutrition disorders         
Anorexia  1  2/5 (40.00%)  2/8 (25.00%)  0/3 (0.00%)  0/6 (0.00%) 
Hyperglycemia  1  1/5 (20.00%)  2/8 (25.00%)  0/3 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders         
Proteinuria  1  2/5 (40.00%)  0/8 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnea  1  0/5 (0.00%)  1/8 (12.50%)  1/3 (33.33%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders         
Rash  1  3/5 (60.00%)  2/8 (25.00%)  3/3 (100.00%)  1/6 (16.67%) 
Palmar-plantar erythrodysesthesia syndrome  1  2/5 (40.00%)  2/8 (25.00%)  2/3 (66.67%)  1/6 (16.67%) 
Vascular disorders         
Hypertension  1  1/5 (20.00%)  1/8 (12.50%)  1/3 (33.33%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.
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.
The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Results Point of Contact
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Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01035658     History of Changes
Other Study ID Numbers: SCRI GYN 26
First Submitted: December 17, 2009
First Posted: December 21, 2009
Results First Submitted: December 16, 2014
Results First Posted: May 21, 2015
Last Update Posted: April 11, 2016