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Sponsors and Collaborators: |
Ariad Pharmaceuticals Merck |
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Information provided by: | Ariad Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00538239 |
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 |
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Metastatic Soft-Tissue Sarcomas Metastatic Bone Sarcomas |
Drug: deforolimus Drug: Placebo |
Phase III |
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 |
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 |
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1: Experimental |
Drug: deforolimus
40 mg, Oral, QDx5 (five consecutive days each week followed by two day holiday) until disease progression
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2: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll-Free Phone Number (US callers only) | 877-621-2302 | |
Contact: International callers | 1-617-621-2302 |
Study Director: | ARIAD Medical Monitor | ARIAD Pharmaceuticals, Inc. 617-494-0400 |
Responsible Party: | ARIAD Pharmaceuticals, Inc. ( Frank Haluska, M.D. ) |
Study ID Numbers: | AP23573-07-302 |
Study First Received: | September 28, 2007 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00538239 |
Health Authority: | United States: Food and Drug Administration |
Neoplasms, Connective and Soft Tissue Malignant mesenchymal tumor Sarcoma Soft tissue sarcomas |
Neoplasms Neoplasms by Histologic Type |