A Multicenter, Open-label, Dose-escalation, Phase I Study of TAK-733, an Oral MEK Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies

Millennium Pharmaceuticals, Inc.2 sites in 1 country51 target enrollmentDecember 2009

ConditionsAdvanced Non-hematologic Malignancies Advanced Metastatic Melanoma

InterventionsTAK-733

DrugsTAK-733

Overview

Phase: Phase 1
Intervention: TAK-733
Conditions: Advanced Non-hematologic Malignancies
Sponsor: Millennium Pharmaceuticals, Inc.
Enrollment: 51
Locations: 2
Primary Endpoint: Safety profile, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and maximum tolerated dose of TAK-733 in patients with advanced, nonhematologic tumors. The expansion stage of the study will evaluate evidence of antitumor activity of TAK-733 in patients with advanced metastatic melanoma.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Millennium Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Each patient must meet all of the following inclusion criteria to be enrolled in the study:
•18 years or older.
•Have one of the following diagnoses: a nonhematologic malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective; OR have stage 3 or stage 4 unresectable melanoma not priorly treated with either MEK or BRAF inhibitor therapy.
•Melanoma patients should have the V600E BRAF mutation status of their tumor documented, if available, and tumor tissue must be provided for confirmatory genotyping by a central laboratory.
•Have a radiographically or clinically evaluable tumor.
•Have suitable venous access for the conduct of blood sampling.
•Provide voluntary written consent, which can be withdrawn by the patient at any time.
•Female patients who: are post-menopausal for at least 1 year before screening; OR are surgically sterile; OR if they are of childbearing potential agree to practice two effective methods of birth control from the time of signing the informed consent form through 30 days after the last dose of the study drug, or agree to completely abstain from heterosexual intercourse.
•Male patients, even if surgically sterilized, must agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of the study drug; OR agree to completely abstain from heterosexual intercourse.

Exclusion Criteria

•Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
•Female patients who are lactating or have a positive serum pregnancy test during the Screening period.
•Antineoplastic therapy or radiotherapy within 21 days; or nitrosoureas of mitomycin C within 42 days
•Prior biologic or immunotherapy ≤ 4 weeks prior to enrollment.
•Grade 2 or greater unresolved toxicity (except alopecia) from previous anticancer therapy.
•Major surgery within 14 days of the first dose of the study drug.
•An active infection requiring systemic therapy; or other severe infection.
•Symptomatic brain metastases.
•Inability to meet specific laboratory test standards during the Screening period as specified in the study protocol.
•Human Immunodeficiency (HIV) positive.

Arms & Interventions

TAK-733

Intervention: TAK-733

Outcomes

Primary Outcomes

Safety profile, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733

Time Frame: 12 months

Pharmacokinetic characterization of TAK-733

Time Frame: 12 months

Secondary Outcomes

Effect of food on the pharmacokinetics of TAK-733(12 months)
Antitumor activity of TAK-733 in patients with advanced nonhematologic malignancies(12 months)
Antitumor activity of TAK-733 in melanoma patients(12 months)