Safety Study of AP23573 in Patients With Advanced, Refractory or Recurrent Malignancies (8669-013)(COMPLETED)

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Ariad Pharmaceuticals
• Treatments: Sirolimus

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 hormonal therapy.

• 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.