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

NCT ID: NCT00538239

Last Updated: 2015-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 711 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Metastatic Soft-Tissue Sarcomas; Metastatic Bone Sarcomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ridaforolimus

Group Type: EXPERIMENTAL

ridaforolimus

Intervention Type: DRUG

Four 10 mg tablets taken by mouth for 5 days per week continuously

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Four 10 mg tablets taken by mouth for 5 days per week continuously

Interventions

ridaforolimus

Four 10 mg tablets taken by mouth for 5 days per week continuously

Intervention Type: DRUG

Placebo

Four 10 mg tablets taken by mouth for 5 days per week continuously

Intervention Type: DRUG

Other Intervention Names

deforolimus; AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009

Eligibility 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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ariad Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. doi: 10.1200/JCO.2012.45.5766. Epub 2013 May 28.

Reference Type: RESULT

PMID: 23715582 (View on PubMed)

Other Identifiers

AP23573-07-302

Identifier Type: -

Identifier Source: secondary_id

8669-011

Identifier Type: -

Identifier Source: org_study_id