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

Millennium Pharmaceuticals, Inc.3 sites in 1 country20 target enrollmentOctober 2009

ConditionsAdvanced Solid Tumors Lymphoma

InterventionsTAK-901

DrugsTAK-901

Overview

Phase: Phase 1
Intervention: TAK-901
Conditions: Advanced Solid Tumors
Sponsor: Millennium Pharmaceuticals, Inc.
Enrollment: 20
Locations: 3
Primary Endpoint: To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

November 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Millennium Pharmaceuticals, Inc.

Responsible Party

Sponsor

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
•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.

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.

Arms & Interventions

TAK-901 Arm

Intervention: TAK-901

Outcomes

Primary Outcomes

To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.

Time Frame: 12 months

To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects.

Time Frame: 12 months

Secondary Outcomes

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)