Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Nonhematologic Malignancies, Carcinoma, Basal Cell

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C24002

NCT ID:

NCT01204073

Start Date:

October 2010

Completion Date:

January 2013

Related Keywords:

  • Advanced Nonhematologic Malignancies
  • Carcinoma, Basal Cell
  • Neoplasms
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location

Mayo ClinicScottsdale, Arizona  
Premiere Oncology, A Medical CorporationSanta Monica, California  90404