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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


Phase 3
13 Years
N/A
Not Enrolling
Both
Metastatic Soft-Tissue Sarcomas, Metastatic Bone Sarcomas

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Trial Information

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


Inclusion Criteria:



- Confirmed diagnosis of metastatic soft-tissue or bone sarcoma

- Ongoing complete response, partial response, or stable disease (RECIST) after a
minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third
line of prior cytotoxic chemotherapy for metastatic disease

- Eastern Cooperative Oncology Group performance status of 0 or 1

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Time Frame:

Up to 157 weeks after randomization

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MK-8669-011

NCT ID:

NCT00538239

Start Date:

October 2007

Completion Date:

December 2012

Related Keywords:

  • Metastatic Soft-Tissue Sarcomas
  • Metastatic Bone Sarcomas
  • Osteosarcoma
  • Sarcoma

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