Clinical trial NCT01204073: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Nonhematologic Malignancies
Carcinoma, Basal Cell
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: From first dose of TAK-441 through 30 days after the last dose of TAK-441
Secondary outcomes:
measure: Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441
timeFrame: Sampling during Cycle 1 (Days 1-28)
measure: Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin
timeFrame: Cycle 1 Day 22
measure: Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only)
timeFrame: Cycle 1 Day 15
measure: 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
timeFrame: Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Santa Monica
country: United States
facility: Premiere Oncology, A Medical Corporation
state: California
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: