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

Phase 3

Completed

• Conditions: Metastatic Bone Sarcomas; Metastatic Soft-Tissue Sarcomas
• Interventions: Drug: Placebo; Drug: ridaforolimus

• Registration Number: NCT00538239
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-09-28
• Study Start: 2007-10
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Primary Completion: 2010-10
• Study Completion: 2012-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 711

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ridaforolimus	ridaforolimus	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	Up to 157 weeks after randomization

Secondary Outcome Measures

Name	Time	Method
Overall survival: First Analysis	Up to 157 weeks after randomization
Best Target Lesion Response (RECIST)	Up to 157 weeks after randomization
Overall Survival: Updated Analysis as of 30 April 2011	Up to 184 weeks after randomization
Overall Survival: Updated Analysis as of 21 January 2012	Up to 222 weeks after randomization
Safety and tolerability	Up to 157 weeks after randomization