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Lenalidomide and Cetuximab in Patients With Advanced Solid Tumors

NCT01166035 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-07-20

No results posted yet for this study

Summary

This is a Phase 1/2, open-label, monocentric, dose-escalation study of lenalidomide in combination with cetuximab in subjects with solid tumors. The primary objective is to establish the maximum tolerated dose (MTD) of lenalidomide in combination with cetuximab in patients with solid tumors including colorectal cancer (CRC), squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC).

Conditions

Interventions

DRUG

Lenalidomide

Lenalidomide will be supplied as 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Prior to Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Subjects will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28. For each cohort of subjects, the decision of whether or not to dose-escalate will be made after subjects have received the first treatment cycle of study drug. Treatment will continue until the occurrence of any of the following events. * Disease progression * Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen. * Major violation of the study protocol. * Withdrawal of consent * Lost to follow up * Death * Suspected pregnancy

DRUG

Cetuximab

Combination treatment will start at Day 1. Subjects meeting will be enrolled in cohorts of three to receive infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Cetuximab will be supplied as Erbitux® 22 mg/ml Vial à 50 ml, Erbitux 5 mg/ml Vial à 10 ml and Erbitux 5 mg/ml Vial à 50 ml for intravenous administration. Treatment will continue until the occurrence of any of the following events. * Disease progression * Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen. * Major violation of the study protocol. * Withdrawal of consent * Lost to follow up * Death * Suspected pregnancy

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Innsbruck - Tyrolean Working Group of Experimental Oncology (TEXO)

    collaborator UNKNOWN

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Heinz Zwierzina, Prof. Dr. · Medical University of Innsbruck, Deparmtment of Internal Medicince I

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Austria

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166035 on ClinicalTrials.gov