Back to resultsA Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies
Primary Purpose
Advanced Nonhematologic Malignancies, Carcinoma, Basal Cell
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TAK-441
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Nonhematologic Malignancies
Eligibility 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
Sites / Locations
- Mayo Clinic
- Premiere Oncology, A Medical Corporation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAK-441
Arm Description
Outcomes
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
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
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
Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only)
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
Based on the investigator's assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Full Information
NCT ID
NCT01204073
First Posted
September 15, 2010
Last Updated
July 1, 2013
Sponsor
Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01204073
Brief Title
A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Nonhematologic Malignancies, Carcinoma, Basal Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAK-441
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TAK-441
Intervention Description
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 Outcome Measure Information:
Title
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
Description
Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements
Time Frame
From first dose of TAK-441 through 30 days after the last dose of TAK-441
Secondary Outcome Measure Information:
Title
Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441
Description
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)
Time Frame
Sampling during Cycle 1 (Days 1-28)
Title
Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin
Time Frame
Cycle 1 Day 22
Title
Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only)
Time Frame
Cycle 1 Day 15
Title
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
Description
Based on the investigator's assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Time Frame
Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Millennium Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Premiere Oncology, A Medical Corporation
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies
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