Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Eval. of the Efficacy of Ridaforolimus)(8669-011) - Full Text View

Sponsor:	Merck
Collaborator:	Ariad Pharmaceuticals
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00538239

Purpose

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	Intervention	Phase
Metastatic Soft-Tissue Sarcomas Metastatic Bone Sarcomas	Drug: ridaforolimus Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: AP 23573

U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Enrollment:	711
Study Start Date:	October 2007
Estimated Study Completion Date:	January 2012
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ridaforolimus	Drug: ridaforolimus 40 mg, Oral, QDx5 (five consecutive days each week followed by two day holiday) until disease progression Other Names: deforolimus AP23573 MK-8669 ridaforolimus was also known as deforolimus until May 2009
Placebo Comparator: Placebo	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 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

Contacts and Locations

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

Show 155 Study Locations

Sponsors and Collaborators

Merck

Ariad Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00538239 History of Changes
Other Study ID Numbers:	AP23573-07-302
Study First Received:	September 28, 2007
Last Updated:	July 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteosarcoma
Sarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sirolimus
Antibiotics, Antineoplastic

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 12, 2012