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

NCT01204073 | Completed Phase 1

• 2 other identifiers: C240022010-021311-17
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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

Outcome Measures

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

  Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements

  From first dose of TAK-441 through 30 days after the last dose of TAK-441

Secondary Outcomes (4)

• Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441

  Sampling during Cycle 1 (Days 1-28)

• Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin

  Cycle 1 Day 22

• Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only)

  Cycle 1 Day 15

• 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

  Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study

Study Arms (1)

TAK-441

EXPERIMENTAL

Drug: TAK-441

Interventions

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

TAK-441

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (2)

Mayo Clinic

Scottsdale, Arizona, 85259-5499, United States

Location

Premiere Oncology, A Medical Corporation

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

TAK-441

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: July 2, 2013

Record last verified: 2013-07

Locations

US (2)