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A Phase II Study of MK-8669 When Administered as Maintenance Therapy to Japanese Patients With Metastatic Bone or Soft-tissue Sarcomas


Phase 2
13 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

A Phase II Study of MK-8669 When Administered as Maintenance Therapy to Japanese Patients With Metastatic Bone or Soft-tissue Sarcomas


Inclusion Criteria:



- Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized,
and who derive benefit following chemotherapy.

- Eastern Cooperative Oncology Group (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 central nervous system (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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free rate (PFR) at 6 months

Outcome Description:

Progression free rate at 6 months is defined as the proportion of participants who are a complete response (CR, disappearance of all target lesions), partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions) or stable disease (does not qualify for PR or progressive disease) at 6 months from the date of the first study drug administration.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

8669-030

NCT ID:

NCT01010672

Start Date:

November 2009

Completion Date:

January 2013

Related Keywords:

  • Sarcoma
  • Sarcoma

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