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Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Chemotherapy

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III, Phase II Treatment Active 18 and over Pharmaceutical / Industry CRAD001C2241
NCT00419159

Trial Description

Summary

To assess the efficacy and safety of everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with other chemotherapy

Eligibility Criteria

Inclusion criteria

Age ≥ 18 years old.

Patients with metastatic colorectal cancer (CRC).

Patients must have tumor tissue from original surgical resection.

Patients with documented disease progression within 6 months of their most recent dose of chemotherapeutic regimens

Patients with at least one measurable lesion

Exclusion criteria

Patients currently receiving anti-cancer agents or who have received these within 4 weeks prior to study entry.

Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.

Chronic treatment with steroids or another immunosuppressive agent.

Patients with untreated central nervous system (CNS) metastases or neurologically unstable CNS metastases.

HIV seropositivity.

Patients with an active, bleeding diathesis. Patients may use enoxaparin.

Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study

Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to first study treatment.

Other protocol defined inclusion/exclusion criteria may apply

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Novartis

Study Chair

Novartis U.S.

Ph: 862 778 8300

Novartis Basel

Ph: 41 61 324 1111

Trial Sites

U.S.A.

Nevada

Las Vegas

Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00419159
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.