ARIAD has launched its global Phase 3 clinical trial of oral ridaforolimus (formerly named deforolimus), a novel mTOR inhibitor, in patients with metastatic soft-tissue and bone sarcomas. The SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus) trial is a randomized, double-blind, placebo-controlled study. In this pivotal trial, we will assess the impact of oral ridaforolimus on progression-free survival (PFS), the primary endpoint of the trial, and overall survival as a secondary endpoint, in patients with metastatic sarcomas who have achieved a favorable response to chemotherapy.
Sarcomas are a group of aggressive cancers of connective tissue in the body for which there are currently limited treatment options. Continued treatment with traditional chemotherapeutic drugs has not been established to provide additional clinical benefit after a patient achieves a favorable response to such treatment. Thus, absent new alternatives, physicians generally either continue potentially toxic chemotherapy until the side effects become unacceptable or, more commonly, monitor patients carefully for disease progression or tumor growth (“watchful waiting”), prior to initiating another line of chemotherapy. Therefore, the placebo arm in SUCCEED represents a current standard of care for patients in this clinical setting.
Our SUCCEED trial looks to shift the paradigm of potential treatment options for patients with sarcoma.
Study objectives
- Primary: to determine the rate of progression-free survival (PFS) for patients treated with ridaforolimus
- Secondary: to assess overall survival (OS), best target lesion response, improvement in symptoms, and safety and tolerability with ridaforolimus
Study design
- Multicenter, international, randomized, Phase 3, double-blind, placebo-controlled study
- Approximately 650 patients will be randomized (1:1) to oral ridaforolimus or placebo at approximately 125 sites, worldwide
Key eligibility criteria
- Confirmed diagnosis of metastatic soft-tissue or bone sarcoma
- Ongoing favorable outcome after a minimum of 4 cycles of prior chemotherapy for treatment of metastatic disease in sarcoma patients
- ECOG performance status of 0 or 1
- Age 13 years or greater
- Adequate organ and bone marrow function
- Completed prior chemotherapy with last dose received at least 3 and up to 8 weeks prior to randomization
ARIAD and Merck & Co., Inc. have a global collaboration to jointly develop and commercialize ridaforolimus for treatment of cancer.