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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Metastatic Soft-Tissue Sarcomas; Metastatic Bone Sarcomas

Treatments: Drug: Placebo; Drug: ridaforolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00538239

AP23573-07-302

8669-011

Details and patient eligibility

About

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.

Enrollment: 711 patients

Sex: All

Ages: 13+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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711 participants in 2 patient groups, including a placebo group

Ridaforolimus

Experimental group

Treatment:

Drug: ridaforolimus

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo