NCT00398879

Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients

A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or capecitabine alone. The effects of perifosine may be manifested by increased time to progression, tumor regression reflected in partial or complete responses, or a combination of these outcomes. The primary goal of this trial is to obtain a preliminary and objective assessment of the effects of perifosine on time to progression.

Detailed description

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. If there is any evidence of improved time to progression in any tumor type with any of the drugs to be evaluated, the initial study or component(s) of the study will be expanded to increase the certainty that this is an effect of perifosine. If there is compelling evidence of benefit from this study, a phase 3 trial will be conducted to obtain proof of principle. Primary Study Objectives: To determine the time to tumor progression when receiving single agent chemotherapy (capecitabine) in combination with perifosine in comparison to patients receiving single agent chemotherapy (capecitabine) alone (i.e., with placebo). Secondary Study Objectives: * To determine the toxicity of single agent chemotherapy in combination with perifosine. * To compare the time to progression of chemotherapy in combination with placebo to historical experience. * Overall survival will also be evaluated.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Perifosine	Perifosine 50 mg/d qd
DRUG	Capecitabine	Capecitabine 825 mg/m\^2 BID days 1 - 14 q 3 weeks
OTHER	Perifosine Placebo	Placebo to Perifosine 50 mg/d qd

Timeline

• Start date: 2005-08-01
• Primary completion: 2010-12-01
• Completion: 2011-10-01
• First posted: 2006-11-14
• Last updated: 2018-03-14

Locations

49 sites across 1 country: United States