Study of TAK-901 in Adults With Advanced Solid Tumors or Lymphoma
- Registration Number
- NCT00935844
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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 exclusion criteria are not to be enrolled in the study:
- Diagnosis of primary CNS malignancy or carcinomatous meningitis.
- Patient has symptomatic brain metastasis.
- Prior bone allogeneic bone marrow or stem cell transplant.
- Prior radiotherapy involving > or equal to 30% of the hematopoietically active bone marrow, within 21 days before the start of the study drug.
- Systemic antineoplastic therapy within 28 days before the start of the study drug, except for luteinizing hormone-releasing-hormone (LHRH) agonist therapy.
- Exposure to nitrosureas or mitomycin C within 42 days before the start of the study drug.
- Treatment with monoclonal antibodies within 28 days before the start of the study drug.
- Known allergy or hypersensitivity to compounds of similar chemical composition to TAK-901 or its excipient, Captisol.
- Female patients who are lactating or who have a positive serum pregnancy test during the screening period or a positive serum pregnancy test during the screening period.
- Myocardial infarction within 6 months before enrollment.
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Abnormalities on 12-lead electrocardiogram (ECG) as specified in the protocol.
- Infection requiring systemic anti-infective therapy within 14 days before the start of study drug.
- Known human immunodeficiency virus (HIV)positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- Diagnosed or treated for another malignancy within 2 years before the start of study drug or previously diagnosed with another malignancy and have any evidence of residual disease.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.
- Treatment with any investigational products within 28 days before the first dose of study drug.
- Systemic use of strong CYP3A inhibitors or inducers (as specified in the protocol) within 14 days before the first dose of study drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAK-901 Arm TAK-901 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
The University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Fox Chase Cancer Center
🇺🇸Rockledge, Pennsylvania, United States