Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer

NCT ID: NCT01449370

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when administered orally in subjects with advanced solid malignancies.

Conditions

Metastatic Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

TAK-117 administered once a day orally

Group Type: EXPERIMENTAL

TAK-117

Intervention Type: DRUG

oral administration of TAK-117, daily and intermittent schedules.

Arm B

TAK-117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week

Group Type: EXPERIMENTAL

TAK-117

Intervention Type: DRUG

oral administration of TAK-117, daily and intermittent schedules.

Arm C

TAK-117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week

Group Type: EXPERIMENTAL

TAK-117

Intervention Type: DRUG

oral administration of TAK-117, daily and intermittent schedules.

Interventions

TAK-117

oral administration of TAK-117, daily and intermittent schedules.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects have had their PIK3CA gene mutation status assessed prior to enrolling into the study
• Subjects must have documented disease progression prior to enrolling into the study
• locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy.
• Age greater than or equal to (>=) 18 years, including males and females;
• Eastern cooperative oncology group (ECOG) performance status (PS) 0-1;
• Adequate organ function;
• Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
• Ability to swallow oral medications;
• Ability to understand and willingness to sign informed consent prior to initiation of any study procedures;
• For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration

Exclusion Criteria

• Diagnosis of primary brain tumor; untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
• Received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug;
• Have received a systemic corticosteroid within one week prior to the first administration of study drug;
• Clinically significant cardiac disease;
• Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug;
• Malabsorption ;
• Poorly controlled diabetes mellitus;
• Pregnancy (positive serum or urine pregnancy test) or breast feeding;
• Untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
• Failed to recover from the reversible effects of prior anticancer therapies;
• Have received a selective phosphoinositide-3-kinase alpha isoform (PI3K-alpha) inhibitor
• Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system (CNS) disease, active infection, or any other condition that could compromise the subject's participation in the study
• Known human immunodeficiency virus (HIV) infection
• Have a secondary malignancy within the last 3 years prior to first dose of study drug, excluding treated non-melanoma skin cancer, carcinoma in situ, or locally-treated prostate cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Boston, Massachusetts, United States

Detroit, Michigan, United States

Dallas, Texas, United States

Barcelona, , Spain

Sutton, , United Kingdom

Countries

United States; Spain; United Kingdom

Other Identifiers

INK1117-001

Identifier Type: -

Identifier Source: org_study_id