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

Plain-language summary

This study evaluated increasing doses of a drug called TAK-117 in people with advanced or metastatic solid tumors. It enrolled patients over 18 whose PIK3CA gene mutation status had been assessed and whose disease had progressed on standard therapy. It was carried out in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Millennium Pharmaceuticals, Inc.

Intervention

TAK-117

Start date

10/1/2011

Estimated completion

1/1/2016

Countries

United States, Spain, United Kingdom

Related genes

Locations

• Boston, United States
• Detroit, United States
• Dallas, United States
• Barcelona, Spain
• Sutton, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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