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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Advanced Solid Tumors
• Intervention / Treatment: Drug: TAK-901

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States
      • The University of Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Center
  • Pennsylvania
    • Rockledge, Pennsylvania, United States, 19046
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TAK-901 Arm

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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Millennium Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 8, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Lymphoma; Advanced solid tumors
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: C19001