Advanced Solid Tumors, Lymphoma
Conditions
Keywords
Advanced solid tumors, Lymphoma
Brief summary
This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will help to identify the recommended phase 2 dose and infusion duration, and describe the pharmacokinetics of TAK-901.
Interventions
DRUGTAK-901
This study consists of three sequential parts. Part 1: Escalating doses of TAK-901 will be administered via IV infusion over a 3-hour period on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle. Part 2: Escalating doses of TAK-901 (starting at one-third of the dose identified as the MTD in Part 1) will be administered as a 1-hour infusion on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle. Part 3: TAK-901 will be administered to approximately 20 patients using the dose identified as the MTD in the escalation phase. The infusion duration of TAK-901 will be determined after completion of Part 2.
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 criteria to be enrolled in the study: * ECOG performance status of \< or equal to 2. * Diagnosis of solid tumor malignancy or lymphoma for which standard treatment is no longer effective. * Have a radiographically or clinically evaluable tumor or lymphoma. * Measurable disease as described in the protocol. * Suitable venous access for the study-required blood sampling. * Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse. * Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse. * Voluntary written consent. * Weigh at least 45 kg. * Recovered from the reversible effects of prior antineoplastic therapy. * Meet clinical laboratory values during the screening period as specified in the protocol. * Left ventricular ejection fraction (LVEF) \> or equal to 50% by echocardiogram or multiple acquisition scan (MUGA).
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion. | 12 months |
| To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I). | 12 months |
| To evaluate disease response. | 12 months |
| To investigate the effect of TAK-901 on tumor proliferation. | 12 months |
Countries
United States
Outcome results
None listed