A PHASE 2, OPEN-LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LENALIDOMIDE IN COMBINATION WITH CETUXIMAB IN PRETREATED SUBJECTS WITH KRAS MUTANT METASTATIC COLORECTAL CANCER

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

1.Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
2.At least one unidimensionally measurable lesion.
3.Documented KRAS mutant tumor (paraffin tumor blocks or approximately 25 unstained slides must be sent for KRAS mutation testing and results reported by central pathology laboratory prior to study enrollment).
4.Imaging confirmed (CT/MRI) disease progression within 42 days of previous treatment.
5.Disease progression on oxaliplatin- AND irinotecan-containing regimens in the metastatic setting, with at least one of these regimens containing bevacizumab.
6.Eastern Cooperative Oncology Group performance status of = 1.
7.Women of childbearing potential must undergo pregnancy testing based on the frequency outlined in Section 21.3 or 21.4 and pregnancy results must be negative.
8.Unless practicing complete abstinence from heterosexual intercourse, sexually active WCBP must agree to use adequate contraceptive methods as specified in Section 21.3 or 21.4.
9.Males (including those who have had a vasectomy) must use barrier contraception (condom) when engaging in sexual activity with WCBP as specified in Section 21.3 or 21.4.
10.Males must agree not to donate semen or sperm during the duration specified in Section 21.3 or 21.4.
11. All subjects must:
•Understand that the investigational product could have a potential teratogenic risk.
•Agree to abstain from donating blood while taking investigational product and following discontinuation of investigational product (see Section 21.3 or 21.4).
•Agree not to share study medication with another person.
•Be counseled about pregnancy precautions and risks of fetal exposure (see Section 21.3 or 21.4).
12.Understand and voluntarily sign an ICF.
13.Age = 18 years at the time of signing the ICF.
14.Able to adhere to the study visit schedule and other protocol requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Use of chemotherapy, hormonal therapy, immunotherapy, or any other anticancer or experimental therapy = 28 days prior to Cycle 1 Day 1.
2.Radiotherapy to = 30% of the bone marrow.
3.Surgery = 28 days prior to Cycle 1 Day 1 (minimally invasive procedures for the purpose of diagnosis or staging of the disease are permitted).
4.Prior therapy with cetuximab.
5.Prior therapy with panitumumab.
6.Prior therapy with pomalidomide (CC-4047), lenalidomide, or thalidomide.
7.Absolute neutrophil count (ANC) < 1.5 x 109/L.
8.Platelet count < 100 x 109/L.
9.Creatinine Clearance < 50 mL/min (by Cockroft- Gault).
10.Bilirubin > 1.5 x ULN (> 2.0 x ULN in the presence of Gilbert’s Syndrome).
11.Serum AST or ALT > 3.0 x ULN (> 5 x ULN in the presence of liver metastases).
12.Hemoglobin < 9 g/dL.
13.Untreated, symptomatic brain metastases (brain imaging not required).
14.Venous thromboembolism = 6 months prior to Cycle 1 Day 1.
15.Current congestive heart failure (New York Heart Association class II-IV).
16.Myocardial Infarction (MI) = 12 months prior to Cycle 1 Day 1.
17.Uncontrolled hypertension.
18.Prior malignancies within 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin or in-situ” carcinoma of the cervix or breast.
19.Any condition (psychological, familial, sociological or geographical), including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study, confound the ability to interpret data from the study, or not allow the subject to comply with the requirements of the study protocol.
20.Pregnant or lactating women.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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