Phase II Study of MK8669 With Metastatic Bone or Soft-tissue Sarcoma Patients

This study is currently recruiting participants.

Verified by Merck, June 2010

First Received: November 6, 2009 Last Updated: June 23, 2010 History of Changes

Sponsor:	Merck
Collaborator:	Ariad Pharmaceuticals
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT01010672

Purpose

The study evaluates efficacy of MK 8669 when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.

Condition	Intervention	Phase
Sarcoma	Drug: ridaforolimus	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of MK8669 When Administered as Maintenance Therapy to Patients With Metastatic Bone or Soft-tissue Sarcomas

Resource links provided by NLM:

MedlinePlus related topics: 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 rate (PFR) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ridaforolimus	Drug: ridaforolimus MK8669 oral tablet, 40 mg once daily for 5 consecutive days followed by 2-day dosing holiday each week.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy.
ECOG performance status of 0 or 1
Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
Adequate organ and bone marrow function

Exclusion Criteria:

Presence of brain or CNS metastases, unless successfully treated
Prior therapy with rapamycin or rapamycin analogs
Ongoing toxicity associated with prior anticancer therapy
History or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation, or pose an additional risk to the patient

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010672

Locations

Japan, Chiyodaku
Merck Ltd., Japan	Recruiting
Tokyo, Chiyodaku, Japan, 102-8667
Contact: Tadaaki Taniguchi 81-3-6272-1547

Sponsors and Collaborators

Merck

Ariad Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
ClinicalTrials.gov Identifier:	NCT01010672 History of Changes
Other Study ID Numbers:	2009_688, MK8669-030
Study First Received:	November 6, 2009
Last Updated:	June 23, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Sarcoma
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 September 07, 2010