Overview

Safety Study of Ridaforolimus in Patients With Advanced, Refractory or Recurrent Malignancies (MK-8669-001 AM5)(COMPLETED)

Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
All
Summary
Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of ridaforolimus 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% (Eastern Cooperative Oncology
Group [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 central nervous system (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 human immunodeficiency virus (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 over-the-counter (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.