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Trial record 66 of 880 for:    LENALIDOMIDE

A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer

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: NCT01032291
Recruitment Status : Terminated (A business decision not to continue with Phase 2b based on non-safety observations during proof of concept phase.)
First Posted : December 15, 2009
Results First Posted : May 21, 2013
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: cetuximab
Drug: lenalidomide
Enrollment 51
Recruitment Details  
Pre-assignment Details Phase 2b Proof of Concept was designed to enroll 82 participants, however the study terminated early. Forty-three participants were enrolled, however, one was randomized to receive single agent lenalidomide but never received study drug and was excluded from the ITT and Safety populations.
Arm/Group Title Lenalidomide + Cetuximab (Safety Lead-in) Lenalidomide (Proof of Concept) Lenalidomide + Cetuximab (Proof of Concept)
Hide Arm/Group Description Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle). Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period. Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Period Title: Safety Lead-in
Started 8 0 0
Completed 6 [1] 0 0
Not Completed 2 0 0
Reason Not Completed
Adverse Event             1             0             0
Death             1             0             0
[1]
Participants with disease progression
Period Title: Proof of Concept
Started 0 22 21
Intent to Treat and Safety Populations 0 21 [1] 21 [1]
Completed 0 14 [2] 18 [2]
Not Completed 0 8 3
Reason Not Completed
Adverse Event             0             5             1
Death             0             1             2
Lack of Efficacy             0             1             0
Never Received Study Drug             0             1             0
[1]
Participants who took at least one dose of study drug
[2]
Participants with disease progression
Arm/Group Title Lenalidomide Plus Cetuximab (Safety Lead-In) Lenalidomide (Proof of Concept) Lenalidomide Plus Cetuximab (Proof of Concept) Total
Hide Arm/Group Description Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle). Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period. Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle). Total of all reporting groups
Overall Number of Baseline Participants 8 21 21 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 21 participants 21 participants 50 participants
<= 65 years 7 16 18 41
>65 years 1 5 3 9
[1]
Measure Description: All baseline measures are reported from the safety population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 21 participants 21 participants 50 participants
Female
4
  50.0%
9
  42.9%
9
  42.9%
22
  44.0%
Male
4
  50.0%
12
  57.1%
12
  57.1%
28
  56.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 21 participants 21 participants 50 participants
Caucasian (White) 8 21 20 49
Other (Not Specified) 0 0 1 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 21 participants 21 participants 50 participants
Hispanic or Latino 0 0 0 0
Non-Hispanic or Latino 8 21 21 50
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 21 participants 21 participants 50 participants
0 6 10 14 30
1 2 10 7 19
2 0 1 0 1
3-5 0 0 0 0
[1]
Measure Description:

The ECOG scale is as follows:

Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.

1.Primary Outcome
Title Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period
Hide Description

The number of participants with DLTs determines the maximum tolerated dose of the combination therapy used in the Proof of Concept (POC) period:

If <2 of the initial 6 participants experience a DLT, then the POC will start with lenalidomide at 25 mg.

If ≥2 of the initial 6 participants experienced a DLT, then 6 more subjects were to be enrolled at 20 mg lenalidomide.

If <2 of the additional 6 subjects experienced a DLT, then the lenalidomide starting dose for the POC was to be 20 mg.

If ≥2 of the additional 6 subjects experienced a DLT, then 6 more subjects were to be enrolled at 15 mg lenalidomide.

If <2 of the additional 6 subjects experienced a DLT, then the POC was to start with lenalidomide at 15 mg.

If ≥2 of the additional 6 subjects experienced a DLT, the dosing for the study was to be reassessed by Celgene Corporation and the investigators.

Time Frame Up to Day 28 (Cycle 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of study medication. If a participant discontinued the study prior to completing the entire first cycle for reasons other than a DLT or if ≥7 days of lenalidomide and/or ≥1 dose of cetuximab were missed during the first cycle for reasons other than a DLT, a replacement would be added at that dose level.
Arm/Group Title Lenalidomide Plus Cetuximab (Safety Lead-in)
Hide Arm/Group Description:
Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
1
2.Primary Outcome
Title Percentage of Participants With a Response to Treatment During the Proof of Concept Period
Hide Description

Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).

Treatment response includes both complete response and partial response.

  • Complete response-disappearance of all lesions
  • Partial response-30% decrease in the sum of diameters of target lesions from baseline

Analysis was not performed due to the early termination of the study.

Time Frame week 9 up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population. Analysis was not performed due to the early termination of the study.
Arm/Group Title Lenalidomide (Proof of Concept) Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)
Hide Arm/Group Description:
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Kaplan-Meier Estimates for Progression Free Survival (PFS)
Hide Description

PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD), or death on study due to any cause.

Analysis was not performed due to the early termination of the study.

Time Frame up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.
Arm/Group Title Lenalidomide Plus Cetuximab (Safety Lead-In) Lenalidomide (Proof of Concept) Lenalidomide Plus Cetuximab (Proof of Concept)
Hide Arm/Group Description:
Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Kaplan-Meier Estimates for Duration of Response
Hide Description

Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR).

Analysis was not performed due to the early termination of the study.

Time Frame up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.
Arm/Group Title Lenalidomide Plus Cetuximab (Safety Lead-In) Lenalidomide (Proof of Concept) Lenalidomide Plus Cetuximab (Proof of Concept)
Hide Arm/Group Description:
Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants With Disease Control
Hide Description

Known as the Disease Control Rate (DCR), participants with a complete response, partial response or stable disease contribute to the DCR.

This analysis was not performed due to the early termination of the study.

Time Frame up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.
Arm/Group Title Lenalidomide Plus Cetuximab (Safety Lead-In) Lenalidomide (Proof of Concept) Lenalidomide Plus Cetuximab (Proof of Concept)
Hide Arm/Group Description:
Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Kaplan-Meier Estimates for Overall Survival
Hide Description

Overall survival was defined as the time between randomization and death. It was intended that participants would be followed for up to 5 years following discontinuation from treatment.

Analysis was not performed due to the early termination of the study.

Time Frame up to 5.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.
Arm/Group Title Lenalidomide Plus Cetuximab (Safety Lead-In) Lenalidomide (Proof of Concept) Lenalidomide Plus Cetuximab (Proof of Concept)
Hide Arm/Group Description:
Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events (TEAE)
Hide Description TEAEs are any adverse event occurring or worsening on or after the first treatment of any study drug and within 28 days after the last dose of the last study drug received. Relation to study drug was determined by the investigator. Severity of AE is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.0. Severity is a 5-point scale: 3= severe or medically significant but not life-threatening 4=life-threatening, urgent intervention required 5=death related to AE.
Time Frame up to week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least one dose of study treatment.
Arm/Group Title Lenalidomide Plus Cetuximab (Safety Lead-In) Lenalidomide (Proof of Concept) Lenalidomide Plus Cetuximab (Proof of Concept)
Hide Arm/Group Description:
Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Overall Number of Participants Analyzed 8 21 21
Measure Type: Number
Unit of Measure: participants
>=1 TEAE 8 20 21
Serious TEAE 5 9 9
TEAE leading to discontinuing lenalidomide 3 7 5
TEAE leading to discontinuing cetuximab 3 NA [1]  6
TEAE leading to reduction/interruption of lenalido 2 6 9
TEAE leading to reduction/interruption of cetuxima 1 NA [1]  7
TEAE related to lenalidomide 5 9 13
TEAE related to cetuximab 8 NA [1]  19
TEAE NCI CTC grade 3 or higher 4 13 12
TEAE NCI CTC grade 3+ related to lenalidomide 3 4 4
TEAE NCI CTC grade 3+ related to cetuximab 2 NA [1]  7
Serious TEAE related to lenalidomide 2 0 2
Serious TEAE related to cetuximab 2 NA [1]  2
[1]
Cetuximab not taken by this treatment arm
8.Post-Hoc Outcome
Title Best Overall Response Assessed by an Independent Review Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) During the Proof of Concept Period Prior to Early Study Termination
Hide Description

Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).

  • Complete response-disappearance of all lesions
  • Partial response-30% decrease in the sum of diameters of target lesions from baseline
  • Stable disease-neither shrinkage nor increase of lesions.
  • Progressive Disease-20% increase in the sum of diameters of target lesions from nadir.

Participants with evidence of objective tumor response have the response confirmed with repeat assessments performed at the next scheduled scan.

Time Frame Week 9 up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population.
Arm/Group Title Lenalidomide (Proof of Concept) Lenalidomide Plus Cetuximab (Proof of Concept)
Hide Arm/Group Description:
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0
Partial Response 0 0
Stable Disease 3 5
Progressive Disease 13 13
Response Not Evaluable 5 3
Time Frame up to 28 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide (Proof of Concept) Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)
Hide Arm/Group Description Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period. Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
All-Cause Mortality
Lenalidomide (Proof of Concept) Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide (Proof of Concept) Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/21 (42.86%)   14/29 (48.28%) 
Cardiac disorders     
Tachycardia  1  0/21 (0.00%)  1/29 (3.45%) 
Gastrointestinal disorders     
Abdominal pain  1  2/21 (9.52%)  0/29 (0.00%) 
Diarrhoea  1  0/21 (0.00%)  2/29 (6.90%) 
Constipation  1  1/21 (4.76%)  0/29 (0.00%) 
Intestinal Obstruction  1  0/21 (0.00%)  1/29 (3.45%) 
Intestinal Perforation  1  0/21 (0.00%)  1/29 (3.45%) 
Large Intestine Perforation  1  1/21 (4.76%)  0/29 (0.00%) 
Rectal Obstruction  1  1/21 (4.76%)  0/29 (0.00%) 
General disorders     
General Physical Health Deterioration  1  2/21 (9.52%)  3/29 (10.34%) 
Pyrexia  1  1/21 (4.76%)  1/29 (3.45%) 
Asthenia  1  1/21 (4.76%)  1/29 (3.45%) 
Oedema  1  0/21 (0.00%)  1/29 (3.45%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  0/21 (0.00%)  2/29 (6.90%) 
Immune system disorders     
Hypersensitivity  1  0/21 (0.00%)  1/29 (3.45%) 
Infections and infestations     
Infection  1  1/21 (4.76%)  1/29 (3.45%) 
Septic shock  1  0/21 (0.00%)  1/29 (3.45%) 
Investigations     
C-Reactive Protein Increased  1  0/21 (0.00%)  1/29 (3.45%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  0/21 (0.00%)  1/29 (3.45%) 
Musculoskeletal and connective tissue disorders     
Bone Lesion  1  0/21 (0.00%)  1/29 (3.45%) 
Back Pain  1  1/21 (4.76%)  0/29 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to Central Nervous System  1  0/21 (0.00%)  1/29 (3.45%) 
Metastases to Liver  1  1/21 (4.76%)  0/29 (0.00%) 
Metastases to Lung  1  1/21 (4.76%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/21 (0.00%)  2/29 (6.90%) 
Pulmonary Embolism  1  0/21 (0.00%)  1/29 (3.45%) 
Pleural Effusion  1  1/21 (4.76%)  0/29 (0.00%) 
Respiratory Failure  1  0/21 (0.00%)  1/29 (3.45%) 
Skin and subcutaneous tissue disorders     
Urticaria  1  0/21 (0.00%)  1/29 (3.45%) 
Vascular disorders     
Hypertension  1  0/21 (0.00%)  1/29 (3.45%) 
Extrinsic Vascular Compression  1  1/21 (4.76%)  0/29 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide (Proof of Concept) Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)
Affected / at Risk (%) Affected / at Risk (%)
Total   16/21 (76.19%)   29/29 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  2/21 (9.52%)  3/29 (10.34%) 
Gastrointestinal disorders     
Diarrhoea  1  1/21 (4.76%)  14/29 (48.28%) 
Abdominal pain  1  5/21 (23.81%)  9/29 (31.03%) 
Nausea  1  4/21 (19.05%)  10/29 (34.48%) 
Constipation  1  3/21 (14.29%)  6/29 (20.69%) 
Vomiting  1  2/21 (9.52%)  7/29 (24.14%) 
Abdominal pain upper  1  1/21 (4.76%)  5/29 (17.24%) 
Stomatitis  1  0/21 (0.00%)  4/29 (13.79%) 
Ascites  1  2/21 (9.52%)  1/29 (3.45%) 
Enteritis  1  0/21 (0.00%)  2/29 (6.90%) 
General disorders     
Fatigue  1  6/21 (28.57%)  11/29 (37.93%) 
Asthenia  1  6/21 (28.57%)  9/29 (31.03%) 
Oedema peripheral  1  4/21 (19.05%)  5/29 (17.24%) 
Pyrexia  1  3/21 (14.29%)  6/29 (20.69%) 
Chills  1  0/21 (0.00%)  2/29 (6.90%) 
Mucosal inflammation  1  0/21 (0.00%)  2/29 (6.90%) 
Xerosis  1  0/21 (0.00%)  2/29 (6.90%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  4/21 (19.05%)  2/29 (6.90%) 
Infections and infestations     
Paronychia  1  0/21 (0.00%)  3/29 (10.34%) 
Nasopharyngitis  1  0/21 (0.00%)  2/29 (6.90%) 
Investigations     
Alanine aminotransferase increased  1  3/21 (14.29%)  1/29 (3.45%) 
Aspartate aminotransferase increased  1  3/21 (14.29%)  1/29 (3.45%) 
Transaminases increased  1  2/21 (9.52%)  2/29 (6.90%) 
Weight decreased  1  1/21 (4.76%)  3/29 (10.34%) 
Blood alkaline phosphatase increased  1  3/21 (14.29%)  0/29 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  3/21 (14.29%)  7/29 (24.14%) 
Hypocalcaemia  1  2/21 (9.52%)  2/29 (6.90%) 
Hypokalaemia  1  1/21 (4.76%)  3/29 (10.34%) 
Hypomagnesaemia  1  0/21 (0.00%)  2/29 (6.90%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/21 (4.76%)  6/29 (20.69%) 
Pain in extremity  1  1/21 (4.76%)  3/29 (10.34%) 
Arthralgia  1  0/21 (0.00%)  3/29 (10.34%) 
Muscle spasms  1  1/21 (4.76%)  2/29 (6.90%) 
Flank pain  1  0/21 (0.00%)  2/29 (6.90%) 
Nervous system disorders     
Dysgeusia  1  1/21 (4.76%)  2/29 (6.90%) 
Headache  1  0/21 (0.00%)  3/29 (10.34%) 
Polyneuropathy  1  0/21 (0.00%)  2/29 (6.90%) 
Psychiatric disorders     
Anxiety  1  2/21 (9.52%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  4/21 (19.05%)  3/29 (10.34%) 
Cough  1  0/21 (0.00%)  4/29 (13.79%) 
Skin and subcutaneous tissue disorders     
Rash  1  6/21 (28.57%)  20/29 (68.97%) 
Dry skin  1  0/21 (0.00%)  8/29 (27.59%) 
Pruritis  1  2/21 (9.52%)  6/29 (20.69%) 
Skin fissures  1  0/21 (0.00%)  5/29 (17.24%) 
Erythema  1  0/21 (0.00%)  4/29 (13.79%) 
Hypertrichosis  1  0/21 (0.00%)  2/29 (6.90%) 
Palmar-Plantar erythrodysaesthesia syndrome  1  0/21 (0.00%)  2/29 (6.90%) 
Skin hyperpigmentation  1  0/21 (0.00%)  2/29 (6.90%) 
Vascular disorders     
Hypotension  1  1/21 (4.76%)  2/29 (6.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Enrollment stopped prematurely due to lack of efficacy and failure to achieve the planned response objective.
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.
  • Multicenter publication must include input from investigators and Celgene, agreement to be established before publication
  • Multicenter publication has priority over subset (single center) publication, for duration of 1 year after study completion
  • Individual investigators have publication right after multicenter publication is complete (or 1 year after study completion), whichever is first. In this case, Celgene has the right to comment and right to ask delay of publication for 90 days
Results Point of Contact
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT01032291     History of Changes
Other Study ID Numbers: CC-5013-COLO-001
2009-012665-61 ( EudraCT Number )
First Submitted: December 14, 2009
First Posted: December 15, 2009
Results First Submitted: April 1, 2013
Results First Posted: May 21, 2013
Last Update Posted: May 21, 2013