A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01204073
First received: September 15, 2010
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Advanced Nonhematologic Malignancies
Carcinoma, Basal Cell
Drug: TAK-441
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements


Secondary Outcome Measures:
  • Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441 [ Time Frame: Sampling during Cycle 1 (Days 1-28) ] [ Designated as safety issue: No ]
    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)

  • Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin [ Time Frame: Cycle 1 Day 22 ] [ Designated as safety issue: No ]
  • Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only) [ Time Frame: Cycle 1 Day 15 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Based on the investigator's assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)


Enrollment: 34
Study Start Date: October 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204073

Locations
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.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01204073     History of Changes
Other Study ID Numbers: C24002, 2010-021311-17
Study First Received: September 15, 2010
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Neoplasms
Carcinoma
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 22, 2014