A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies

July 1, 2013 updated by: Millennium Pharmaceuticals, Inc.
The purpose of this study is to determine the maximum tolerated dose (MTD) of TAK-901 in subjects with advanced hematological malignancies, and to further assess the safety and tolerability of TAK-901 at or below the MTD in an expanded cohort of subjects in order to select a dose for future studies.

Study Overview

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

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

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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

Main Inclusion Criteria:

  1. The subject has one of the following confirmed diseases that is refractory to or relapsed from established therapies. Note: A subject with one of these disease who is intolerant (as defined in the protocol) to established therapies is also allowed:

    1. Acute myelogenous leukemia
    2. Acute lymphoblastic leukemia
    3. Chronic myelogenous leukemia (CML) (chronic phase, accelerated phase, or blast crisis)
    4. Chronic lymphocytic leukemia
    5. Multiple myeloma
    6. Waldenstrom's macroglobulinemia
    7. Intermediate or high risk myelodysplastic syndrome
    8. One of the following myeloproliferative disorders:

      • Philadelphia chromosome-negative CML (including blast phase).
      • All subtypes of myeloid metaplasia with myelofibrosis.
      • Advanced polycythemia vera in the spent phase (ie, presence of anemia).
    9. Non-Hodgkins lymphoma
  2. The interval between the last prior treatment and the start of study drug administration is at least 30 days for radiotherapy, at least 14 days for cytotoxic chemotherapy (42 days for nitrosureas or mitomycin C), and at least 5 half-lives for noncytotoxic agents. The only exception is hydroxyurea, which can be used prior to starting study drug and during Cycle 1, as defined in the protocol.
  3. For subjects with prior autologous bone marrow or peripheral blood stem cell transplantation, the interval between transplant and the start of study drug administration is at least 30 days.
  4. For subjects with prior allogeneic bone marrow or peripheral blood stem cell transplantation, the interval between transplant and the start of study drug administration is at least 90 days.
  5. If taking steroids chronically, the subject has been receiving a stable steroid dose for at least 21 days prior to the start of study drug administration, and the daily steroid dose does not exceed the equivalent of 20 mg prednisone.
  6. The subject is aged 18 years or older.
  7. The subject weighs at least 45 kg.
  8. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  9. The subject has adequate liver and kidney function.
  10. The subject has adequate heart function (left ventricular ejection fraction ≥ 50%).

Main Exclusion Criteria:

Any subject who meets any of the following criteria will not qualify for entry into the study:

  1. The subject has a platelet count (untransfused) < 50,000/mm3 and/or an absolute neutrophil count < 1000/mm3 that is not caused by the underlying disease infiltrating the bone marrow.
  2. The subject has evidence of active malignancy in the central nervous system (CNS)or has had CNS involvement documented within the past 90 days. Subjects who are receiving maintenance intrathecal chemotherapy for previous CNS involvement but have no current evidence of disease are allowed if the CNS involvement was documented more than 90 days ago.
  3. The subject has any evidence of acute or chronic graft versus host disease.
  4. The subject has a history of hypersensitivity or allergic reactions attributed to compounds of similar chemical composition to TAK-901 or its excipient, Captisol.
  5. The subject is pregnant or lactating.
  6. The subject has had a myocardial infarction, cerebrovascular accident, transient ischemic attack, clinically significant ventricular arrhythmia, or pulmonary embolus within 6 months prior to the start of study drug administration.
  7. The subject's electrocardiogram demonstrates an abnormal QT interval , as defined by the protocol.
  8. The subject requires dialysis.
  9. The subject is on systemic anticoagulation therapy.
  10. The subject has an uncontrolled intercurrent illness as defined in the protocol.
  11. The subject is known to have human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
  12. The subject has a currently active second malignancy other than nonmelanoma skin cancer or in situ carcinoma of the cervix. A malignancy is considered to be currently active if the subject is receiving ongoing therapy or has been in remission for less than 2 years prior to the first dose of study drug.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
TAK-901
TAK-901 will be administered via IV infusion over a 3-hour period on Days 1,4,8,11,15,18,22, and 25 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the maximum tolerated dose(MTD)of TAK-901 in subjects with advanced hematologic malignancies.
Time Frame: Duration of the study
Duration of the study
To further assess the safety and tolerability of TAK-901 at or below the MTD in an expanded cohort of subjects in order to select a dose for future studies.
Time Frame: Duration of study
Duration of study

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I).
Time Frame: Duration of the study
Duration of the study
To make a preliminary assessment of the clinical activity of TAK-901.
Time Frame: Duration of therapy
Duration of therapy
To make a preliminary assessment of the effects of TAK-901 on pharmacodynamic biomarkers.
Time Frame: Duration of therapy
Duration of therapy
To make a preliminary assessment of the association between selected genetic markers and TAK-901 response and/or pharmacokinetic parameters.
Time Frame: Duration of therapy
Duration of therapy

Collaborators and Investigators

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

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

March 1, 2009

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 11, 2008

First Posted (ESTIMATE)

December 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2013

Last Update Submitted That Met QC Criteria

July 1, 2013

Last Verified

July 1, 2013

More Information

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.

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