Completed

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

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What is being tested

ridaforolimus

Drug
Who is being recruted

Hematologic Malignancies
+2

+ Leukemia
+ Myelodysplastic Syndromes
Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: August 19, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004Actual date on which the first participant was enrolled.

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

Official TitleA Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies 
Principal SponsorMerck Sharp & Dohme LLC
Last updated: August 19, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
57 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hematologic Malignancies
Leukemia
Myelodysplastic Syndromes
Myeloid Metaplasia
Lymphoma
Criteria

Inclusion Criteria (Patients must meet each of the following criteria to be eligible for participation in the trial): * 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 (Patients meeting any of the following criteria are ineligible for participation in the study): * 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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 8 locations
Suspended
University of Chicago Hospitals, Section of Hematology/OncologyChicago, United StatesSee the location
Suspended
Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview PlaceSt. Louis, United States
Suspended
The Cancer Institute of New JerseyNew Brunswick, United States
Suspended
New York Presbyterian Hospital, Weill College of Cornell UniversityNew York, United States

Completed8 Study Centers