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

This study has been completed.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00538239
First received: September 28, 2007
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Metastatic Soft-Tissue Sarcomas
Metastatic Bone Sarcomas
Drug: ridaforolimus
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival: First Analysis [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ]
  • Best Target Lesion Response (RECIST) [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ]
  • Overall Survival: Updated Analysis as of 30 April 2011 [ Time Frame: Up to 184 weeks after randomization ] [ Designated as safety issue: No ]
  • Overall Survival: Updated Analysis as of 21 January 2012 [ Time Frame: Up to 222 weeks after randomization ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: Yes ]

Enrollment: 711
Study Start Date: October 2007
Study Completion Date: December 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00538239     History of Changes
Other Study ID Numbers: 8669-011, AP23573-07-302
Study First Received: September 28, 2007
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteosarcoma
Sarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014