Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-06-30

Brief Summary

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The purpose of this phase II study is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies.

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Detailed Description

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The primary objective of the trial is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies by evaluating the response rates as defined for the individual malignancy categories. Secondary objectives include evaluating time to disease progression, progression-free survival and duration of response; evaluating the pharmacokinetic and pharmacodynamic characteristics of AP23573; describing health-related quality of life measurements; and exploring the safety and tolerability of AP23573 at the specified dose level.

Protocol Outline: Open label, non-randomized parallel cohorts of five disease-specific cohorts with a minimum of 21 patients per cohort. Each patient receives a fixed dose of AP23573 administered intravenously (IV) over 30 minutes daily for five days (QDx5) to be repeated every 2 weeks.

Conditions

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Hematologic Malignancies Leukemia Myelodysplastic Syndromes Myeloid Metaplasia Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks

Group Type EXPERIMENTAL

ridaforolimus

Intervention Type DRUG

AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks

Interventions

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ridaforolimus

AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks

Intervention Type DRUG

Other Intervention Names

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deforolimus AP23573 MK-8669 ridaforolimus was also known as deforolimus until May 2009

Eligibility Criteria

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Inclusion Criteria

* Male or female patients ≥ 18 years of age
* Patients must have histologically-confirmed diagnoses of relapsed or refractory hematologic malignancy as specified in the protocol
* Patients must have an ECOG performance status of 0 to 2
* Patients must have adequate renal and liver function as demonstrated by laboratory values performed within 5 days, inclusive, prior to administration of the first dose of AP23573
* Patients must be able to understand and give written informed consent

Exclusion Criteria

* Women who are pregnant or lactating
* Patients may not have had cytotoxic chemotherapy or radiotherapy within 14 days prior to study entry
* Patients may not receive any investigational anti-cancer agent while on this study or within 14 days prior to the first dose of AP23573
* Patients with known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug formulation
* Patients with known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
* Patients with significant uncontrolled cardiovascular disease
* Patients with known HIV infection
* Patients with any uncontrolled infection
* Patients receiving immunosuppressive agents other than prescribed corticosteroids
* Patients who have had prior therapy with rapamycin, any rapamycin analog or tacrolimus
* Patients with inadequate recovery from any prior surgical procedure or patients having undergone any major surgical procedure within 14 days prior to the first dose of AP23573
* Patients with 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 study 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 another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinomas in situ)
* Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements

Drugs and Other Treatments to be Excluded (The following drugs and other treatments are not permitted for patients enrolling in the study, either during or within two weeks prior to the first dose of AP23573, unless otherwise specified):

* Chemotherapeutic agents with the following exception that therapy with nitrosoureas (including generics) cannot be given within six weeks prior to the first dose of AP23573
* Other antineoplastic agents
* Immunotherapy (including vaccines) or biological response modifier therapy
* Systemic hormonal therapy with exceptions as specified in the protocol
* Herbal preparations or related OTC preparations containing herbal ingredients (e.g., St John's Wort)
* Radiotherapy for the primary malignancy
* Any other investigational agent during the course of the trial should be discussed with the Sponsor prior to use

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No