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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00538239
• Collaborator: Ariad Pharmaceuticals (Industry)
• Enrollment: 711
• Arms: 2
• Duration (Months): 62

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Soft-Tissue Sarcomas; Metastatic Bone Sarcomas	Drug: ridaforolimus; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 711 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ridaforolimus	Drug: ridaforolimus; Four 10 mg tablets taken by mouth for 5 days per week continuously; Other Names: deforolimus AP23573 MK-8669 ridaforolimus was also known as deforolimus until May 2009
Placebo Comparator: Placebo	Drug: Placebo; Four 10 mg tablets taken by mouth for 5 days per week continuously

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival [Up to 157 weeks after randomization]

Secondary Outcome Measures

1. Overall survival: First Analysis [Up to 157 weeks after randomization]

2. Best Target Lesion Response (RECIST) [Up to 157 weeks after randomization]

3. Overall Survival: Updated Analysis as of 30 April 2011 [Up to 184 weeks after randomization]

4. Overall Survival: Updated Analysis as of 21 January 2012 [Up to 222 weeks after randomization]

5. Safety and tolerability [Up to 157 weeks after randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC
• Ariad Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00538239
• Other Study ID Numbers: 8669-011; AP23573-07-302
• First Posted: Oct 2, 2007
• Last Update Posted: Feb 13, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Sarcoma; Osteosarcoma; Sirolimus

Study Results

No Results Posted as of Feb 13, 2015