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Clinical Trials/EUCTR2009-012665-61-SE
EUCTR2009-012665-61-SEActive, not recruitingNot Applicable

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

Celgene Corporation0 sites220 target enrollmentStarted: October 12, 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
220
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Disease Characteristics:
  • •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

  • •Prior Treatment:
  • •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.
  • •Laboratory:
  • •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.
  • •Other Disease State:
  • •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.

Investigators

Sponsor
Celgene Corporation

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