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A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: cetuximab (Drug); lenalidomide (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Eric Van Cutsem, M.D., Ph,D, Principal Investigator, Affiliation: Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium
Josep Tabernero, M.D., Principal Investigator, Affiliation: Hospital Vall d´Hebrón, Servicio de Oncología, Barcelona. Spain

Summary

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.

Clinical Details

Official title: A Phase 2, Open-Label Study To Evaluate The Efficacy And Safety Of Lenalidomide In Combination With Cetuximab In Pretreated Subjects With K-Ras Mutant Metastatic Colorectal Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period

Percentage of Participants With a Response to Treatment During the Proof of Concept Period

Secondary outcome:

Kaplan-Meier Estimates for Progression Free Survival (PFS)

Kaplan-Meier Estimates for Duration of Response

Percentage of Participants With Disease Control

Kaplan-Meier Estimates for Overall Survival

Participants With Treatment-Emergent Adverse Events (TEAE)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Metastatic colorectal adenocarcinoma. 2. Confirmed K-RAS mutant tumor 3. Disease progression on oxaliplatin- AND irinotecan-containing regimens, with at least one of these regimens containing bevacizumab. 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Exclusion Criteria: 1. Use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or experimental treatment ≤ 28 days prior to the first day of the first cycle. 2. Radiotherapy for up to ≥ 30% of the bone marrow. 3. Surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions for diagnostic purposes or disease staging are permitted). 4. Previous treatment with cetuximab, panitumumab, pomalidomide (CC-4047), lenalidomide or thalidomide. 5. Untreated, symptomatic brain metastases (brain imaging not required). 6. Venous thromboembolism ≤ 6 months before day1 of the first cycle. 7. Current congestive heart failure (classes II to IV of the New York Heart Association). 8. Myocardial infarction ≤ 12 months before day1 of the first cycle. 9. Uncontrolled hypertension.

Locations and Contacts

UZ Antwerpen Dept. of Medical Oncology, Antwerp, Belgium

ULB Erasme Service de Gastroenterologie, Brussels, Belgium

Grand hôpital de Charleroi, Oncologie, Charleroi, Belgium

Algemeen Ziekenhuis Maria Middelares, Gent, Belgium

Universitaire Ziekenhuis Gasthuisberg K.U. Leuven Gastroenterologie, Oncologie, Leuven, Belgium

Centre Hospitalier Universitaire Sart Tilman Liège, Liège, Belgium

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, Milano, Italy

Hospital Vall D'Hebron Servicio de Oncología. Unidad de ensayos clínicos, Barcelona, Spain

Hospital Universitario Marques de Valdecilla Servicio de Oncología, 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

Klinikum Oldenburg gGmbH Klinik für Innere Medizin II, Oldenburg, Niedersachsen, Germany

Flinders Medical Centre, Dept. of Oncology, Bedford Park, South Australia, Australia

Additional Information

Starting date: December 2009
Last updated: April 1, 2013

Page last updated: August 23, 2015

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