Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer (NCT NCT01032291)
NCT ID: NCT01032291
Last Updated: 2013-05-21
Results Overview
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.
TERMINATED
PHASE2
51 participants
Up to Day 28 (Cycle 1)
2013-05-21
Participant Flow
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.
Participant milestones
| Measure |
Lenalidomide + Cetuximab (Safety Lead-in)
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).
|
Lenalidomide (Proof of Concept)
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
|
Lenalidomide + Cetuximab (Proof of Concept)
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).
|
|---|---|---|---|
|
Safety Lead-in
STARTED
|
8
|
0
|
0
|
|
Safety Lead-in
COMPLETED
|
6
|
0
|
0
|
|
Safety Lead-in
NOT COMPLETED
|
2
|
0
|
0
|
|
Proof of Concept
STARTED
|
0
|
22
|
21
|
|
Proof of Concept
Intent to Treat and Safety Populations
|
0
|
21
|
21
|
|
Proof of Concept
COMPLETED
|
0
|
14
|
18
|
|
Proof of Concept
NOT COMPLETED
|
0
|
8
|
3
|
Reasons for withdrawal
| Measure |
Lenalidomide + Cetuximab (Safety Lead-in)
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).
|
Lenalidomide (Proof of Concept)
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
|
Lenalidomide + Cetuximab (Proof of Concept)
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).
|
|---|---|---|---|
|
Safety Lead-in
Adverse Event
|
1
|
0
|
0
|
|
Safety Lead-in
Death
|
1
|
0
|
0
|
|
Proof of Concept
Adverse Event
|
0
|
5
|
1
|
|
Proof of Concept
Death
|
0
|
1
|
2
|
|
Proof of Concept
Lack of Efficacy
|
0
|
1
|
0
|
|
Proof of Concept
Never Received Study Drug
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Lenalidomide Plus Cetuximab (Safety Lead-In)
n=8 Participants
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).
|
Lenalidomide (Proof of Concept)
n=21 Participants
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
|
Lenalidomide Plus Cetuximab (Proof of Concept)
n=21 Participants
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
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<= 65 years
|
7 participants
n=5 Participants
|
16 participants
n=7 Participants
|
18 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Age, Customized
>65 years
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian (White)
|
8 participants
n=5 Participants
|
21 participants
n=7 Participants
|
20 participants
n=5 Participants
|
49 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other (Not Specified)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
8 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
0
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
1
|
2 participants
n=5 Participants
|
10 participants
n=7 Participants
|
7 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
2
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
3-5
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28 (Cycle 1)Population: 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.
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.
Outcome measures
| Measure |
Lenalidomide Plus Cetuximab (Safety Lead-in)
n=8 Participants
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).
|
Lenalidomide Plus Cetuximab (Proof of Concept)
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).
|
Lenalidomide Plus Cetuximab (Proof of Concept)
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).
|
|---|---|---|---|
|
Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period
|
1 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: week 9 up to week 24Population: Efficacy Evaluable Population. Analysis was not performed due to the early termination of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to week 24Population: Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to week 24Population: Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to week 24Population: Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 5.5 yearsPopulation: Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to week 28Population: Participants who took at least one dose of study treatment.
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.
Outcome measures
| Measure |
Lenalidomide Plus Cetuximab (Safety Lead-in)
n=8 Participants
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).
|
Lenalidomide Plus Cetuximab (Proof of Concept)
n=21 Participants
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).
|
Lenalidomide Plus Cetuximab (Proof of Concept)
n=21 Participants
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).
|
|---|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
TEAE related to cetuximab
|
8 participants
|
NA participants
Cetuximab not taken by this treatment arm
|
19 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
TEAE NCI CTC grade 3 or higher
|
4 participants
|
13 participants
|
12 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
TEAE NCI CTC grade 3+ related to lenalidomide
|
3 participants
|
4 participants
|
4 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
Serious TEAE related to lenalidomide
|
2 participants
|
0 participants
|
2 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
Serious TEAE related to cetuximab
|
2 participants
|
NA participants
Cetuximab not taken by this treatment arm
|
2 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
>=1 TEAE
|
8 participants
|
20 participants
|
21 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
Serious TEAE
|
5 participants
|
9 participants
|
9 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
TEAE leading to discontinuing lenalidomide
|
3 participants
|
7 participants
|
5 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
TEAE leading to discontinuing cetuximab
|
3 participants
|
NA participants
Cetuximab not taken by this treatment arm
|
6 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
TEAE leading to reduction/interruption of lenalido
|
2 participants
|
6 participants
|
9 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
TEAE leading to reduction/interruption of cetuxima
|
1 participants
|
NA participants
Cetuximab not taken by this treatment arm
|
7 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
TEAE related to lenalidomide
|
5 participants
|
9 participants
|
13 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
TEAE NCI CTC grade 3+ related to cetuximab
|
2 participants
|
NA participants
Cetuximab not taken by this treatment arm
|
7 participants
|
POST_HOC outcome
Timeframe: Week 9 up to week 24Population: Intent to treat population.
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.
Outcome measures
| Measure |
Lenalidomide Plus Cetuximab (Safety Lead-in)
n=21 Participants
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).
|
Lenalidomide Plus Cetuximab (Proof of Concept)
n=21 Participants
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).
|
Lenalidomide Plus Cetuximab (Proof of Concept)
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).
|
|---|---|---|---|
|
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
Stable Disease
|
3 participants
|
5 participants
|
—
|
|
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
Complete Response
|
0 participants
|
0 participants
|
—
|
|
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
Partial Response
|
0 participants
|
0 participants
|
—
|
|
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
Progressive Disease
|
13 participants
|
13 participants
|
—
|
|
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
Response Not Evaluable
|
5 participants
|
3 participants
|
—
|
Adverse Events
Lenalidomide (Proof of Concept)
Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)
Serious adverse events
| Measure |
Lenalidomide (Proof of Concept)
n=21 participants at risk
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
|
Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)
n=29 participants at risk
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).
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
General disorders
General Physical Health Deterioration
|
9.5%
2/21 • up to 28 weeks.
|
10.3%
3/29 • up to 28 weeks.
|
|
General disorders
Pyrexia
|
4.8%
1/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone Lesion
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
2/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
4.8%
1/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Rectal Obstruction
|
4.8%
1/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
General disorders
Asthenia
|
4.8%
1/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
General disorders
Oedema
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Infections and infestations
Infection
|
4.8%
1/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Infections and infestations
Septic shock
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.8%
1/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
|
4.8%
1/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lung
|
4.8%
1/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.8%
1/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Vascular disorders
Extrinsic Vascular Compression
|
4.8%
1/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
Other adverse events
| Measure |
Lenalidomide (Proof of Concept)
n=21 participants at risk
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
|
Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)
n=29 participants at risk
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).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.5%
2/21 • up to 28 weeks.
|
10.3%
3/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • up to 28 weeks.
|
48.3%
14/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.8%
5/21 • up to 28 weeks.
|
31.0%
9/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • up to 28 weeks.
|
34.5%
10/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
3/21 • up to 28 weeks.
|
20.7%
6/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • up to 28 weeks.
|
24.1%
7/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
1/21 • up to 28 weeks.
|
17.2%
5/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/21 • up to 28 weeks.
|
13.8%
4/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Ascites
|
9.5%
2/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
General disorders
Fatigue
|
28.6%
6/21 • up to 28 weeks.
|
37.9%
11/29 • up to 28 weeks.
|
|
General disorders
Asthenia
|
28.6%
6/21 • up to 28 weeks.
|
31.0%
9/29 • up to 28 weeks.
|
|
General disorders
Oedema peripheral
|
19.0%
4/21 • up to 28 weeks.
|
17.2%
5/29 • up to 28 weeks.
|
|
General disorders
Pyrexia
|
14.3%
3/21 • up to 28 weeks.
|
20.7%
6/29 • up to 28 weeks.
|
|
General disorders
Chills
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
General disorders
Xerosis
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
19.0%
4/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Infections and infestations
Paronychia
|
0.00%
0/21 • up to 28 weeks.
|
10.3%
3/29 • up to 28 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
3/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
3/21 • up to 28 weeks.
|
3.4%
1/29 • up to 28 weeks.
|
|
Investigations
Transaminases increased
|
9.5%
2/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Investigations
Weight decreased
|
4.8%
1/21 • up to 28 weeks.
|
10.3%
3/29 • up to 28 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
3/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
3/21 • up to 28 weeks.
|
24.1%
7/29 • up to 28 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.5%
2/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
1/21 • up to 28 weeks.
|
10.3%
3/29 • up to 28 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • up to 28 weeks.
|
20.7%
6/29 • up to 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • up to 28 weeks.
|
10.3%
3/29 • up to 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/21 • up to 28 weeks.
|
10.3%
3/29 • up to 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
1/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Nervous system disorders
Dysgeusia
|
4.8%
1/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • up to 28 weeks.
|
10.3%
3/29 • up to 28 weeks.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Psychiatric disorders
Anxiety
|
9.5%
2/21 • up to 28 weeks.
|
0.00%
0/29 • up to 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.0%
4/21 • up to 28 weeks.
|
10.3%
3/29 • up to 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • up to 28 weeks.
|
13.8%
4/29 • up to 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
6/21 • up to 28 weeks.
|
69.0%
20/29 • up to 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/21 • up to 28 weeks.
|
27.6%
8/29 • up to 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.5%
2/21 • up to 28 weeks.
|
20.7%
6/29 • up to 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/21 • up to 28 weeks.
|
17.2%
5/29 • up to 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • up to 28 weeks.
|
13.8%
4/29 • up to 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar erythrodysaesthesia syndrome
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • up to 28 weeks.
|
6.9%
2/29 • up to 28 weeks.
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee * 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
- Publication restrictions are in place
Restriction type: OTHER