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

August 18, 2015 updated by: Merck Sharp & Dohme LLC

A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals, Section of Hematology/Oncology
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • The Cancer Institute of New Jersey
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital, Weill College of Cornell University
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Morris Cancer Center - Duke University Medical Center, Adult Bone Marrow Transplant Clinic
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Jeane's Hospital of TUHS
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
Drug: ridaforolimus
AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
Other Names:
  • deforolimus
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess efficacy of AP23573 in patients with relapsed or refractory hematologic malignancies.
Time Frame: Duration of study
Duration of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluating time to progression, progression-free survival, duration of response and safety
Time Frame: Duration of study
Duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Ariad Pharmaceuticals

Investigators

  • Study Director: Frank Haluska, M.D., Ph.D., Ariad Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

June 24, 2004

First Submitted That Met QC Criteria

June 25, 2004

First Posted (Estimate)

June 28, 2004

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8669-024
  • AP23573-04-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on ridaforolimus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe