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Completed

NCT Number: NCT01204073

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

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.

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Key information

Conditions

Advanced Nonhematologic Malignancies Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAK-441

Drug

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Sep 17, 2010
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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