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

NCT ID: NCT01204073

Last Updated: 2013-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-01-31

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.

Conditions

Advanced Nonhematologic Malignancies; Carcinoma, Basal Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAK-441

Group Type: EXPERIMENTAL

TAK-441

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• Voluntary written consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Mayo Clinic

Scottsdale, Arizona, United States

Premiere Oncology, A Medical Corporation

Santa Monica, California, United States

Countries

United States

Other Identifiers

2010-021311-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C24002

Identifier Type: -

Identifier Source: org_study_id