| September 28, 2007 |
| November 13, 2009 |
| September 2007 |
| June 2014 (final data collection date for primary outcome measure) |
| Progression-free Survival [ Time Frame: Duration of the study ] [ Designated as safety issue: No ] |
| Progression-free Survival |
| Complete list of historical versions of study NCT00538239 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Overall survival, antitumor response, change in cancer-related symptoms, safety, and tolerability. |
| |
| Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Eval. of the Efficacy of Ridaforolimus) |
| 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 |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
- Metastatic Soft-Tissue Sarcomas
- Metastatic Bone Sarcomas
|
- Drug: ridaforolimus
- Drug: Placebo
|
| |
| |
| |
| Recruiting |
| 650 |
| June 2014 |
| June 2014 (final data collection date for primary outcome measure) |
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 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
|
| Both |
| 13 Years and older |
| No |
| Contact: Toll-Free Phone Number (US callers only) |
877-621-2302 |
|
|
| Contact: International callers |
1-617-621-2302 |
|
|
|
| United States, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Slovakia, South Africa, Spain, Sweden, United Kingdom |
| |
| NCT00538239 |
| Frank Haluska, M.D., ARIAD Pharmaceuticals, Inc. |
| AP23573-07-302 |
| Ariad Pharmaceuticals |
| Merck |
| Study Director: |
ARIAD Medical Monitor |
ARIAD Pharmaceuticals, Inc. 617-494-0400 |
|
|
| Ariad Pharmaceuticals |
| November 2009 |
