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Safety Study of AP23573 in Patients With Advanced, Refractory or Recurrent Malignancies
This study has been completed.
First Received: May 8, 2003   Last Updated: May 29, 2009   History of Changes
Sponsored by: Ariad Pharmaceuticals
Information provided by: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00060632
  Purpose

Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of AP23573 in patients with refractory or recurrent malignancies, including myeloma and lymphoma.


Condition Intervention Phase
Tumors
Lymphoma
Multiple Myeloma
Drug: ridaforolimus
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Weekly Administration of AP23573, an mTOR Inhibitor, in Patients With Refractory or Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Ariad Pharmaceuticals:

Estimated Enrollment: 48
Study Start Date: April 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The primary objectives of the study are to determine the safety, tolerability, and MTD of AP23573 when administered once weekly for 4 weeks (4 week cycle). The secondary objectives of the study are to characterize the pharmacokinetic profile of AP23573, to evaluate potential pharmacodynamic markers of AP23573, and to obtain preliminary information on the antineoplastic activity of AP23573.

Protocol Outline: This is a dose-escalation study. Patients receive AP23573 over 30 minutes by intravenous infusion once weekly for 8 weeks (two 4-week cycles). If tolerated, a total of at least 2 cycles will be administered (8-week treatment period). Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. ˇ

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(Patients must meet each of the following criteria to be eligible for participation in the study).

  • Male or female patients, ≥ 18 years of age.
  • Patients with a documented measurable or evaluable malignancy, including myeloma or lymphoma, that is recurrent, advanced, or metastatic.
  • Patients with disease that is currently refractory to, or not amenable to, standard therapy.
  • Patients with disease that is currently not amenable to surgical intervention.
  • Patients with Karnofsky performance status of ≥ 70% (ECOG performance status of 0 or 1) and an anticipated life expectancy of ≥ 3 months.
  • Patients either not of childbearing potential, or agreeing to use a medically effective method of contraception.
  • Patients with the ability to understand and give written informed consent.

Exclusion Criteria:

(Patients meeting any of the following criteria are ineligible for participation in the study)

  • Women who are pregnant or lactating.
  • Patients with primary CNS malignancies. Patients with leukemia, any form.
  • Patients with certain hematologic abnormalities.
  • Patients with certain serum chemistry abnormalities at baseline.
  • Patients with known or suspected hypersensitivity to either drugs formulated with polysorbate 80 (Tween 80) or any other excipient contained in the test drug formulation.
  • Patients with known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin).
  • Patients with significant cardiovascular disease.
  • Patients with active CNS metastases (or leptomeningeal disease) not controlled by prior surgery or radiotherapy. Note: Patients with treated brain metastases will be eligible if they are on a stable dose of corticosteroids or are without change in brain disease status for at least 4 weeks following related therapy (e.g., whole brain radiation, surgery).
  • Patients with known HIV infection.
  • Patients with any active infection.
  • Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 2 weeks prior to study entry. Note: Patients having undergone recent placement of a central venous access port will be considered eligible for enrollment if they have recovered.
  • Patients who have 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 evaluation of the safety of the test drug.
  • Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
  • Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements.

Drugs and Other Treatments to be Excluded (Either during or within 4 weeks prior to study entry, unless otherwise noted)

  • Chemotherapeutic agents (standard or experimental).
  • Other antineoplastic agents.
  • Immunotherapy (including vaccines) or biological response modifier therapy.
  • Systemic replacement hormonal therapy for life-threatening non-oncology diseases.
  • Herbal preparations or related OTC preparations containing herbal ingredients (e.g., St John's Wort) during or within 2 weeks prior to study entry.
  • Any prior therapy with rapamycin, CCI-779, or any other rapamycin analog.
  • Any other experimental therapy during the course of the study.
  • Radiotherapy for the primary malignancy or metastases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060632

Locations
United States, Illinois
Pritzker School of Medicine, University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Ariad Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: AP23573-02-101
Study First Received: May 8, 2003
Last Updated: May 29, 2009
ClinicalTrials.gov Identifier: NCT00060632     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Ariad Pharmaceuticals:
Advanced, refractory or recurrent solid tumors

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Recurrence
Multiple Myeloma
Lymphatic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on July 02, 2009