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FOLFOX/Bevacizumab +/- MK-0646 in Metastatic Colorectal Cancer

NCT01175291 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2011-12-05

No results posted yet for this study

Summary

The purpose is to study the efficacy (effectiveness) of a new drug, MK-0646, in metastatic colorectal cancer. MK-0646 is an investigational or experimental anti-cancer agent that has not yet been approved by the U.S. Food and Drug Administration (FDA) for use in metastatic colorectal cancer or any other disease.

This study will assess whether adding MK-0646 to an FDA-approved standard of care chemotherapy improves participants' duration of progression-free survival. MK-0646 is believed to inhibit the receptor of a protein called IGF-1 (Insulin-like Growth Factor) which is thought to contribute to cancer development and growth. However, there is no guarantee that MK-0646 will slow cancer development and growth.

Other purposes of this study include:

* looking at the safety and tolerability of MK-0646
* comparing MK-0646 + standard of care chemotherapy with placebo + standard of care chemotherapy (placebo is a substance that looks like an active drug but has no active ingredient) The standard of care chemotherapy in this study is called FOLFOX 7. FOLFOX 7 includes the drugs oxaliplatin with leucovorin, 5-Fluorouracil (5-FU), and bevacizumab.

Conditions

Interventions

DRUG

MK-0646

ARM A will receive FOLFOX 7 (Oxaliplatin with leucovorin + 5-Fluorouracil \[5-FU\] + Bevacizumab) + MK-0646 (Investigational).

DRUG

Placebo

ARM B will receive FOLFOX 7 (Oxaliplatin with leucovorin + 5-Fluorouracil \[5-FU\] + Bevacizumab) + placebo: standard of care chemotherapy plus placebo.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

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Entities

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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 NCT01175291 on ClinicalTrials.gov