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

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ClinicalTrials.gov Identifier: NCT00538239
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : February 13, 2015
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 Type : Interventional  (Clinical Trial)
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 : October 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Up to 157 weeks after randomization ]

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


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
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

Additional Information:
Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00538239     History of Changes
Other Study ID Numbers: 8669-011
AP23573-07-302
First Posted: October 2, 2007    Key Record Dates
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