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Trial record 2 of 2 for:    TAK-901

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00807677
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 12, 2008
Last Update Posted Date July 2, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2008)
  • To determine the maximum tolerated dose(MTD)of TAK-901 in subjects with advanced hematologic malignancies. [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2008)
  • To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I). [ Time Frame: Duration of the study ]
  • To make a preliminary assessment of the clinical activity of TAK-901. [ Time Frame: Duration of therapy ]
  • To make a preliminary assessment of the effects of TAK-901 on pharmacodynamic biomarkers. [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies
Official Title  ICMJE A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Chronic Lymphocytic Leukemia
  • Multiple Myeloma
  • Waldenstrom's Macroglobulinemia
  • Myelodysplastic Syndrome
  • Philadelphia Chromosome-negative CML
  • Myeloid Metaplasia
  • Myelofibrosis
  • Advanced Polycythemia
  • Non-Hodgkins Lymphoma
Intervention  ICMJE Drug: 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.
Study Arms  ICMJE Experimental: 1
TAK-901
Intervention: Drug: TAK-901
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2013)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2008)
65
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00807677
Other Study ID Numbers  ICMJE TAK-901_101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Millennium Pharmaceuticals, Inc.
Study Sponsor  ICMJE Millennium Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
PRS Account Millennium Pharmaceuticals, Inc.
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP