METASTATIC RENAL CELL CARCINOMA MedDRA version: 14.0 Level: LLT Classification code 10038409 Term: Renal cell carcinoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: LLT Classification code 10038415 Term: Renal cell carcinoma stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: LLT Classification code 10038407 Term: Re
Conditions
Interventions
Product Name: GDC-0980
Product Code: GDC-0980 (RO5490254)
Pharmaceutical Form: Film-coated tablet
CAS Number: 1032754-93-0
Current Sponsor code: GDC-0980 (RO5490254)
Other descriptive name: PI3K/mTOR
Sponsors
GENENTECH, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: ?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 disease that is not controlled by nonsteroidal anti inflammatory drugs ?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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) ?To evaluate the safety and tolerability of GDC-0980 versus everolimus ?To assess pharmacokinetic (PK) parameters (Cmax, Cmin) of GDC 0980 and everolimus;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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France, Germany, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line,TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd.
Outcome results
None listed