Study of TAK-901 in Adults With Advanced Solid Tumors or Lymphoma

Lymphoma Clinical Trial

Official title:

An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935844
• Other study ID #: C19001
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2009
• Last updated: December 7, 2011
• Start date: October 2009
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoma

Intervention

Drug:
• TAK-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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan
United States	Karmanos Cancer Center	Detroit	Michigan
United States	Fox Chase Cancer Center	Rockledge	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.		12 months	Yes
Primary	To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects.		12 months	Yes
Secondary	To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I).		12 months	Yes
Secondary	To evaluate disease response.		12 months	No
Secondary	To investigate the effect of TAK-901 on tumor proliferation.		12 months	No