İleri Evre Kanserli Kişilerde TAK-117 (MLN1117) Doz Artırım Çalışması

Sade dilde özet

Bu çalışma, ileri evre veya metastatik solid tümörü (advanced cancer) olan kişilerde TAK-117 adlı ilacın giderek artan dozlarını değerlendirmiştir. Çalışmaya, PIK3CA gen mutasyonu durumu belirlenmiş, standart tedaviyle hastalığı ilerlemiş 18 yaş üstü hastalar alınmıştır. Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

Millennium Pharmaceuticals, Inc.

Müdahale

TAK-117

Başlangıç

01.10.2011

Tahmini bitiş

01.01.2016

Ülkeler

United States, Spain, United Kingdom

İlgili genler

Merkezler

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

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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