A RANDOMIZED, PHASE II, MULTICENTER, PLACEBO-CONTROLLED STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR OF AKT, IN COMBINATION WITH PACLITAXEL AS FRONT-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER.
- Conditions
- Inoperable locally advanced or metastatic triple negative breast cancerMedDRA version: 17.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000469-35-IT
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 124
- Signed Informed Consent Form,
- Premenopausal or postmenopausal women age above or equal to 18 years,
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
- Histologically documented triple negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent,
- Availability of a representative formalin fixed, paraffin embedded (FFPE) tumor specimen that enables a diagnosis of triple negative adenocarcinoma of the breast, accompanied by an associated pathology report, for central molecular analysis (required prior to randomization),
- Measurable disease, according to RECIST v1.1,
- Adequate hematologic and organ function within 14 days before the first study treatment,
- For female patients of childbearing potential, agreement (by both patient and partner) to use an effective form of contraception).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
- Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple negative adenocarcinoma of the breast;
- Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1;
- Known HER2 positive, ER positive, or PR positive breast cancer;
- Previous therapy with Akt, PI3K, and/or mTOR inhibitors;
- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study;
- Known presence of the brain or spinal cord metastasis;
- Need for chronic corticosteroid therapy of 10 mg or more of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressants for a chronic disease;
- Known hypersensitivity or contraindication to any component of the study treatments, including paclitaxel excipient macrogolglycerol ricinoleate;
- Grade equal or above 2 peripheral neuropathy;
- History of Type I or Type II diabetes mellitus requiring insulin;
- New York Heart Association (NYHA) Class II, III, or IV heart failure, or left ventricular ejection fraction < 50%, or active ventricular arrhythmia requiring medication;
- Current unstable angina or history of myocardial infarction within 6 months prior to Cycle 1, Day 1;
- Grade equeal or above 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia;
- Congenital long QT syndrome or screening corrected QT interval (QTc) above 480 milliseconds;
- Bisphosphonate therapy for currently symptomatic hypercalcemia;
- History of malabsorption syndrome, lack of physical integrity of the upper gastrointestinal tract, or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills;
- Active infection requiring intravenous (IV) antibiotics;
- Known clinically significant history of liver disease consistent with Child Pugh Class B or C, including active viral or other hepatitis (e.g., Hepatitis B or Hepatitis C virus), current alcohol abuse, or cirrhosis;
- Known human immunodeficiency virus (HIV) infection;
- Pregnancy, lactation, or breastfeeding;
- Inability to comply with study and follow up procedures;
- Malignancies other than TNBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated surgically with curative intent);
- Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy;
- Active small or large intestine inflammation (such as Crohn’s disease or ulcerative colitis);
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method