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

Phase 1

Completed

• Conditions: Advanced Nonhematologic Malignancies; Carcinoma, Basal Cell
• Interventions: Drug: TAK-441

• Registration Number: NCT01204073
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Study Start: 2010-10
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAK-441	TAK-441	-

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441	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)
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	Based on the investigator's assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Premiere Oncology, A Medical Corporation; 🇺🇸 Santa Monica, California, United States