Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012665-61 | EudraCT Number |
Not provided
Not provided
Not provided
A business decision not to continue with Phase 2b based on non-safety observations during proof of concept phase.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lenalidomide plus cetuximab | Experimental | Combination therapy of lenalidomide plus cetuximab |
|
| lenalidomide | Experimental | Single agent therapy of lenalidomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Drug | Intravenous infusions of cetuximab (400 mg/m^2 Cycle 1 Day 1, thereafter 250 mg/m^2), administered on days 1, 8, 15 and 22 of each 28 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period | 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. | Up to Day 28 (Cycle 1) |
| Percentage of Participants With a Response to Treatment During the Proof of Concept Period | 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.
Analysis was not performed due to the early termination of the study. | week 9 up to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimates for Progression Free Survival (PFS) | 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. | up to week 24 |
| Kaplan-Meier Estimates for Duration of Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Van Cutsem, M.D., Ph,D | Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium | Principal Investigator |
| Josep Tabernero, M.D. | Hospital Vall d´Hebrón, Servicio de OncologÃa, Barcelona. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flinders Medical Centre, Dept. of Oncology | Bedford Park | South Australia | Australia | |||
| UZ Antwerpen Dept. of Medical Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24244687 | Derived | Gandhi AK, Shi T, Li M, Jungnelius U, Romano A, Tabernero J, Siena S, Schafer PH, Chopra R. Immunomodulatory effects in a phase II study of lenalidomide combined with cetuximab in refractory KRAS-mutant metastatic colorectal cancer patients. PLoS One. 2013 Nov 11;8(11):e80437. doi: 10.1371/journal.pone.0080437. eCollection 2013. | |
| 24244261 |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Safety Lead-in |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| lenalidomide | Drug | Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle |
|
|
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. |
| up to week 24 |
| Percentage of Participants With Disease Control | 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. | up to week 24 |
| Kaplan-Meier Estimates for Overall Survival | 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. | up to 5.5 years |
| Participants With Treatment-Emergent Adverse Events (TEAE) | 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. | up to week 28 |
| Antwerp |
| Belgium |
| ULB Erasme Service de Gastroenterologie | Brussels | Belgium |
| Grand hôpital de Charleroi, Oncologie | Charleroi | Belgium |
| Algemeen Ziekenhuis Maria Middelares | Ghent | Belgium |
| Universitaire Ziekenhuis Gasthuisberg K.U. Leuven Gastroenterologie, Oncologie | Leuven | Belgium |
| Centre Hospitalier Universitaire Sart Tilman Liège | Liège | Belgium |
| Klinikum Oldenburg gGmbH Klinik für Innere Medizin II | Oldenburg | Lower Saxony | Germany |
| Azienda Osperdaliero Universitaria Riuniti Umberto I-GM Lancisi-G. Salesi di Ancona Clinica di Oncologia Medica | Ancona | Italy |
| Azienda Ospedaliera Universitaria San Martino Unità Operativa Oncologia Medica | Genova | Italy |
| Azienda Ospedaliera Niguarda Ca' Grande, Oncologia Medica Falck | Milan | Italy |
| Hospital Vall D'Hebron Servicio de OncologÃa. Unidad de ensayos clÃnicos | Barcelona | Spain |
| Hospital Universitario Marques de Valdecilla Servicio de OncologÃa | Santander | Spain |
| Hospital Clinico Universitario de Valencia Servicio de Oncologia | Valencia | Spain |
| Östra Sjukhuset Kirurgkliniken | Gothenburg | Sweden |
| Karolinska University Hospital, Solna, Karolinska Institutet Dept of Oncology | Stockholm | Sweden |
| Akademiska Sjukhuset Onkologkliniken | Uppsala | Sweden |
| Siena S, Van Cutsem E, Li M, Jungnelius U, Romano A, Beck R, Bencardino K, Elez ME, Prenen H, Sanchis M, Sartore-Bianchi A, Tejpar S, Gandhi A, Shi T, Tabernero J. Phase II open-label study to assess efficacy and safety of lenalidomide in combination with cetuximab in KRAS-mutant metastatic colorectal cancer. PLoS One. 2013 Nov 11;8(11):e62264. doi: 10.1371/journal.pone.0062264. eCollection 2013. |
| Lenalidomide (Proof of Concept) |
Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period. |
| FG002 | 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Proof of Concept |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lenalidomide Plus 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). |
| BG001 | Lenalidomide (Proof of Concept) | Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period. |
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | All baseline measures are reported from the safety population. | Number | participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | 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. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period | 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. | 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. | Posted | Number | participants | Up to Day 28 (Cycle 1) |
|
|
| ||||||||||||||||||||||||||
| Post-Hoc | 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 | 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).
Participants with evidence of objective tumor response have the response confirmed with repeat assessments performed at the next scheduled scan. | Intent to treat population. | Posted | Number | participants | Week 9 up to week 24 |
| ||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimates for Progression Free Survival (PFS) | 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. | Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study. | Posted | up to week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimates for Duration of Response | 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. | Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study. | Posted | up to week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Disease Control | 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. | Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study. | Posted | up to week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimates for Overall Survival | 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. | Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study. | Posted | up to 5.5 years |
| ||||||||||||||||||||||||||||||
| Secondary | Participants With Treatment-Emergent Adverse Events (TEAE) | 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. | Participants who took at least one dose of study treatment. | Posted | Number | participants | up to week 28 |
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Response to Treatment During the Proof of Concept Period | 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.
Analysis was not performed due to the early termination of the study. | Efficacy Evaluable Population. Analysis was not performed due to the early termination of the study. | Posted | week 9 up to week 24 |
|
up to 28 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lenalidomide (Proof of Concept) | Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period. | 9 | 21 | 16 | 21 | ||
| EG001 | Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept) | 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). | 14 | 29 | 29 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bone Lesion | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rectal Obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Metastases to Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Metastases to Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Metastases to Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Extrinsic Vascular Compression | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Palmar-Plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Enrollment stopped prematurely due to lack of efficacy and failure to achieve the planned response objective.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Lack of Efficacy |
|
| Never Received Study Drug |
|
| >65 years |
|
| Male |
|
| Other (Not Specified) |
|
| Non-Hispanic or Latino |
|
| 1 |
|
| 2 |
|
| 3-5 |
|
| Units | Counts |
|---|---|
| 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).
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|