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Deforolimus in Treatment of Sarcoma - SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Deforolimus)

This study is currently recruiting participants.
Verified by Ariad Pharmaceuticals, November 2008

Sponsors and Collaborators: Ariad Pharmaceuticals
Merck
Information provided by: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00538239
  Purpose

The purpose of this study is to determine whether maintenance therapy with oral AP23573 (deforolimus), 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: deforolimus
Drug: Placebo
Phase III

MedlinePlus related topics:   Cancer    Soft Tissue Sarcoma   

Drug Information available for:   AP 23573   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
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

Further study details as provided by Ariad Pharmaceuticals:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Anti-tumor response [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Change in cancer-related symptoms [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   650
Study Start Date:   September 2007
Estimated Study Completion Date:   June 2014
Estimated Primary Completion Date:   June 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: deforolimus
40 mg, Oral, QDx5 (five consecutive days each week followed by two day holiday) until disease progression
2: Placebo Comparator Drug: Placebo
Placebo

  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 favorable outcome after a minimum of 4 cycles of prior chemotherapy for metastatic disease
  • ECOG performance status of 0 or 1
  • Age ≥13 years
  • Adequate organ and bone marrow function
  • Completed prior chemotherapy with last dose received at least 3 and up to 8 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538239

Contacts
Contact: Toll-Free Phone Number (US callers only)     877-621-2302    
Contact: International callers     1-617-621-2302    

Show 138 study locations  Show 138 Study Locations

Sponsors and Collaborators
Ariad Pharmaceuticals
Merck

Investigators
Study Director:     ARIAD Medical Monitor     ARIAD Pharmaceuticals, Inc. 617-494-0400    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   ARIAD Pharmaceuticals, Inc. ( Frank Haluska, M.D. )
Study ID Numbers:   AP23573-07-302
First Received:   September 28, 2007
Last Updated:   November 12, 2008
ClinicalTrials.gov Identifier:   NCT00538239
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma
Osteosarcoma
Osteogenic sarcoma
Soft tissue sarcomas

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Bone Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on December 03, 2008




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