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

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

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

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