An evaluation of the investigational drug GDC-0980 in patients with metastatic kidney cancer who have already received up to three therapies, with the approved drug everolimus as a compariso
- Conditions
- METASTATIC RENAL CELL CARCINOMAMedDRA version: 16.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedSystem Organ Class: 100000004864MedDRA version: 16.1Level: LLTClassification code 10038407Term: Renal cell cancerSystem Organ Class: 100000004864MedDRA version: 16.1Level: LLTClassification code 10038409Term: Renal cell carcinoma NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000493-56-DE
- Lead Sponsor
- GENENTECH, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 85
•Histologically or cytologically documented, incurable metastatic renal cell carcinoma with clear-cell component that progressed on or within 6 months of stopping VEGF-targeted therapy
•Age = 18 years
•Karnofsky Performance Status Score (KPSS) of = 70%
•Disease that is measurable per RECIST v1.1
•Adequate hematologic and end organ function
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 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
•Requirement for chronic antihyperglycemic therapy
•Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living
•Decreased oxygen saturation with exercise (pulse oximeter <88%)
•Previously established diagnosis of pulmonary fibrosis of any cause
•Current unstable angina
•History of myocardial infarction within 6 months prior to Day 1
•New York Heart Association (NYHA) Class II or greater congestive heart failure
•Clinically significant liver disease
•Known HIV infection
•Active infection requiring IV antibiotics
•Active autoimmune or inflammatory disease that is not controlled by nonsteroidal anti inflammatory drugs; Patients with active Crohn's disease or ulcerative colitis are not allowed.
•Pregnancy, lactation, or breastfeeding
•Leptomeningeal disease as a manifestation of cancer
•Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control).
•Hypersensitivity to any rapamycin derivatives or to any excipients of everolimus
•History of other malignancies <= 5 years of Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To evaluate the efficacy of GDC-0980 versus everolimus as measured by progression-free survival (PFS) defined as the time from randomization to disease progression;Secondary Objective: •To assess the clinical activity of GDC-0980 versus everolimus as measured by response rate, duration of response, and overall survival (OS)<br>•To evaluate the safety and tolerability of GDC-0980 versus everolimus <br>•To assess pharmacokinetic (PK) parameters (Cmax, Cmin) of GDC 0980 and everolimus<br>;Primary end point(s): Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: After approximately 60 PFS events have occurred (estimated to occur approximately 23 months after study start).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Response rate, duration of response, overall survival, safety, tolerability, PK parameters;Timepoint(s) of evaluation of this end point: Final analyses after approximately 60 PFS events have occurred. Interim analyses for safety and PK parameters after the first 10 patients in each arm have undergone the first tumor assessment while receiving study treatment (GDC-0980 or everolimus); and again when the same is the case for 20 and 30 patients in each arm.