Working… Menu

A Study of TAK-441 in Adult Patients With Advanced Nonhematologic 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. Identifier: NCT01204073
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : July 2, 2013
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Brief Summary:
This is the first study in which TAK-441 is administered to humans. The patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. Following completion of the dose escalation study, patients will be enrolled as part of 2 expansion cohorts.

Condition or disease Intervention/treatment Phase
Advanced Nonhematologic Malignancies Carcinoma, Basal Cell Drug: TAK-441 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Dose-Escalation, Phase 1 Study of TAK-441, an Oral Hedgehog Signaling Pathway Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies
Study Start Date : October 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: TAK-441 Drug: TAK-441

TAK-441 will be administered as an oral tablet as follows:

Patients enrolled in the dose escalation cohorts will receive:

  • A single-dose administration on Day 1, followed by a 1-week washout period during which pharmacokinetics is assessed
  • Continuous daily dosing on Days 8 through 28 in Cycle 1
  • In subsequent cycles, continuous daily dosing over 21 days, repeated continuously

Patients enrolled in the expansion cohorts will receive continuous daily dosing on Days 1 through 21 of each 21-day cycle

Primary Outcome Measures :
  1. Safety profile, maximum tolerated dose (MTD) or maximum feasible dose (MFD) of TAK-441 administered as an oral formulation in patients wtih advanced nonhematologic malignancies [ Time Frame: From first dose of TAK-441 through 30 days after the last dose of TAK-441 ]
    Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements

Secondary Outcome Measures :
  1. Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441 [ Time Frame: Sampling during Cycle 1 (Days 1-28) ]
    Including but not limited to maximum plasma concentration (Cmax), first time to plasma concentration (Tmax) and area under the plasma concentration versus time curve (AUC)

  2. Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin [ Time Frame: Cycle 1 Day 22 ]
  3. Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only) [ Time Frame: Cycle 1 Day 15 ]
  4. Antitumor activity of TAK-441 administered as a single-agent therapy based on investigators' assessments of tumor response in patients who have advanced basal cell carcinoma [ Time Frame: Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study ]
    Based on the investigator's assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • Male or female 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential
  • Meet other clinical, radiographic or laboratory inclusion criteria as specified in the protocol
  • Voluntary written consent

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Life-threatening illness unrelated to cancer
  • Receiving other treatment (radiotherapy, antineoplastics or investigational agents) within protocol specified windows of first dose of TAK-441
  • Patients with brain metastases who do not meet criteria specified in study protocol
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
  • Major surgery within 14 days before the first dose of TAK-441
  • Infection requiring systemic therapy, or other serious infection within 14 days of the first dose of TAK-441
  • Do not meet other clinical, laboratory or radiographic criteria as specified in the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01204073

Layout table for location information
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259-5499
United States, California
Premiere Oncology, A Medical Corporation
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Layout table for investigator information
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Layout table for additonal information
Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT01204073    
Other Study ID Numbers: C24002
2010-021311-17 ( EudraCT Number )
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell