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Completed

NCT Number: NCT00538239

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

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.

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Key information

Conditions

Metastatic Soft-Tissue Sarcomas Bone Diseases Bone Neoplasms Metastatic Bone Sarcomas Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Sarcoma

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ridaforolimus

Drug

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

Drug

Four 10 mg tablets taken by mouth for 5 days per week continuously

Primary outcomes

  1. Progression-free Survival

    Time frame: Up to 157 weeks after randomization

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Ariad Pharmaceuticals

Registry information

Official study 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

Acronym: SUCCEED

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Oct 2, 2007
Registry last updated
Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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