Status:
COMPLETED
Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01449370
Start Date
October 1 2011
End Date
January 1 2016
Last Update
March 9 2017
Active Locations (5)
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1
Boston, Massachusetts, United States
2
Detroit, Michigan, United States
3
Dallas, Texas, United States
4
Barcelona, Spain