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Study of AP23573, an mTOR Inhibitor, in Patients With Advanced Sarcoma
This study is ongoing, but not recruiting participants.
First Received: September 30, 2004   Last Updated: May 29, 2009   History of Changes
Sponsored by: Ariad Pharmaceuticals
Information provided by: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00093080
  Purpose

The purpose of this study is to assess the efficacy of AP23573 in patients with advanced sarcoma when administered once daily for 5 consecutive days (QDx5) every two weeks.


Condition Intervention Phase
Leiomyosarcoma
Liposarcoma
Osteosarcoma
Sarcoma, Soft Tissue
Metastases
Drug: ridaforolimus
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Advanced Sarcoma

Resource links provided by NLM:


Further study details as provided by Ariad Pharmaceuticals:

Primary Outcome Measures:
  • To asses the efficacy of AP23573 in patients with advanced sarcoma [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 212
Study Start Date: September 2004
Estimated Study Completion Date: December 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
12.5 mg of AP23573 is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
Drug: ridaforolimus
12.5 mg of AP23573 is given intravenously over 30 minutes once daily for 5 days, every 2 weeks

Detailed Description:

The primary objective of this study is to assess the efficacy of AP23573 in patients with advanced sarcoma when administered once daily for 5 consecutive days (QDx5) every two weeks. The secondary objectives are to assess the safety & tolerability of this study drug regimen; to evaluate secondary efficacy endpoints, such as time to tumor progression, progression-free survival and duration of response; and to examine AP23573 blood levels and experimental parameters that may predict or indicate response to mTOR inhibition, such as effects on plasma VEGF levels and markers of tumoral PI3K/mTOR-pathway activity.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas*; Any other soft tissue sarcoma* except GIST. * Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months.
  • Presence of at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral CT scan (or otherwise at least twice the reconstruction interval for CT or MRI scans).
  • ECOG performance status ≤1
  • Minimum life expectancy of 3 months
  • Adequate renal and hepatic function, as specified in the protocol.
  • Adequate bone marrow function, as specified in the protocol.
  • Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
  • Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug
  • Able to understand and give written informed consent

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Presence of brain metastases
  • Prior therapy with rapamycin, rapamycin analogues or tacrolimus
  • Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of AP23573
  • Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by NCI toxicity criteria)
  • Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
  • Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug
  • Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
  • Significant uncontrolled cardiovascular disease
  • Active infection requiring systemic therapy
  • Known HIV infection
  • Treatment with any investigational agent within 4 weeks prior to the first dose of AP23573
  • Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug
  • Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of AP23573
  • Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093080

Locations
United States, California
Sant P. Chawla, MD, Inc.
Santa Monica, California, United States, 90403
USC/Norris Comprehensive Cancer Center, LAC+USC Medical Center
Los Angeles, California, United States, 90033
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Cancer Therapy and Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
France
Centre Leon-Berard
Lyon, France
Institut Gustave Roussy
Cedex, France, 94805
Sponsors and Collaborators
Ariad Pharmaceuticals
Investigators
Study Director: Frank Haluska, M.D. Ariad Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ariad Pharmaceuticals, Inc. ( Frank Haluska, M.D. )
Study ID Numbers: AP23573-04-202, EudraCT #:2004-002231-92
Study First Received: September 30, 2004
Last Updated: May 29, 2009
ClinicalTrials.gov Identifier: NCT00093080     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Ariad Pharmaceuticals:
Metastatic and/or unresectable soft tissue or

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Liposarcoma
Leiomyosarcoma
Neoplasm Metastasis
Sarcoma
Osteogenic Sarcoma
Osteosarcoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms by Histologic Type
Leiomyosarcoma
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Liposarcoma
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms, Bone Tissue
Neoplasm Metastasis
Sarcoma
Neoplasms, Connective Tissue
Neoplasms, Adipose Tissue

ClinicalTrials.gov processed this record on August 13, 2009