Advanced Metastatic Melanoma, Advanced Non-hematologic Malignancies
Conditions
Keywords
Advanced nonhematologic malignancies, Advanced metastatic melanoma, BRAF gene
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.
Interventions
DRUGTAK-733
The Initial Escalation Stage will enroll approximately 30 patients with advanced nonhematologic malignancies. TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days. The Expansion Stage will enroll approximately 30 patients with advanced metastatic melanoma. The recommended phase 2 dose determined in the Initial Escalation Stage of TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Provide voluntary written consent, which can be withdrawn by the patient at any time.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733 | 12 months |
| Pharmacokinetic characterization of TAK-733 | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed