Clinical trial NCT00935844: Study of TAK-901 in Adults With Advanced Solid Tumors or Lymphoma
Official title: An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lymphoma
Keywords: Advanced solid tumors
Lymphoma
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.
timeFrame: 12 months
measure: To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects.
timeFrame: 12 months
Secondary outcomes:
measure: To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I).
timeFrame: 12 months
measure: To evaluate disease response.
timeFrame: 12 months
measure: To investigate the effect of TAK-901 on tumor proliferation.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: Rockledge
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: