Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Ariad Pharmaceuticals
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• Confirmed diagnosis of metastatic soft-tissue or bone sarcoma

• Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Adequate organ and bone marrow function

• Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization

Exclusion Criteria:

• Prior therapy with rapamycin or rapamycin analogs

• Ongoing toxicity associated with prior anticancer therapy

• Another primary malignancy within the past three years

• Concomitant medications that induce or inhibit CYP3A

• Significant, uncontrolled cardiovascular disease