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

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

A Pivotal Trial to Determine the Efficacy and Safety of AP23573 When Administered as Maintenance Therapy to Patients With Metastatic Soft-Tissue or Bone Sarcomas

NCT00538239•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

13 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

October 1, 2007

Primary Completion Date

October 1, 2010

Completion Date

December 1, 2012

Last Updated

February 13, 2015

Enrollment

711

ACTUAL participants

Conditions

Metastatic Soft-Tissue SarcomasMetastatic Bone Sarcomas

Interventions

ridaforolimus

DRUG

Placebo

DRUG