We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538239
First Posted: October 2, 2007
Last Update Posted: February 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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: 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

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 ]

Secondary Outcome Measures:
  • Overall survival: First Analysis [ Time Frame: Up to 157 weeks after randomization ]
  • Best Target Lesion Response (RECIST) [ Time Frame: Up to 157 weeks after randomization ]
  • Overall Survival: Updated Analysis as of 30 April 2011 [ Time Frame: Up to 184 weeks after randomization ]
  • Overall Survival: Updated Analysis as of 21 January 2012 [ Time Frame: Up to 222 weeks after randomization ]
  • Safety and tolerability [ Time Frame: Up to 157 weeks after randomization ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00538239     History of Changes
Other Study ID Numbers: 8669-011
AP23573-07-302
First Submitted: September 28, 2007
First Posted: October 2, 2007
Last Update Posted: February 13, 2015
Last Verified: February 2015

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