Study of GDC-0980 Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following Vascular Endothelial Growth Factor- (VEGF) Targeted Therapy
This study is ongoing, but not recruiting participants.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01442090
First received: September 26, 2011
Last updated: May 22, 2013
Last verified: May 2013
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Purpose
Study PIM4973g is a multicenter, international, open-label Phase II trial. Patients with metastatic renal cell carcinoma who have progressed on or after Vascular endothelial growth factor- (VEGF) targeted therapy will be randomized.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Carcinoma |
Drug: Everolimus Drug: GDC-0980 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Open Label, Randomized Study of GDC-0980 Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following VEGF-Targeted Therapy |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Progression-free survival (PFS), defined as the time from randomization to disease progression, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, or death from any cause on study [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective tumor response as assessed by the investigator using RECIST v1.1 [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
- Duration of objective response, defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST v1.1 [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
- Overall survival (OS), defined as the time from treatment initiation until death from any cause [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
| Enrollment: | 85 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: GDC-0980
Oral daily dose
|
| Experimental: B |
Drug: Everolimus
Oral daily dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Disease that is measurable per RECIST v1.1
- Karnofsky performance status of >= 70%
- Adequate hematologic and end organ function
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use two effective forms of contraception and to continue its use for the duration of the study
Exclusion Criteria:
- Any anti-cancer therapy, including chemotherapy, biologic or other targeted therapy, herbal therapy, hormonal therapy, or radiotherapy, within 5 half-lives (for systemic agents) or 2 weeks, whichever is shorter, prior to Day 1
- Requirement for chronic antihyperglycemic therapy
- Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living
- 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
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
- Clinically significant history of liver disease, including cirrhosis and current alcohol abuse
- Presence of positive test results for hepatitis B or hepatitis C
- Known HIV infection
- Active infection requiring IV antibiotics
- Active autoimmune or inflammatory disease that is not controlled by nonsteroidal anti-inflammatory drugs
- Pregnancy, lactation, or breastfeeding
- Current severe, uncontrolled systemic disease
- Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment
- Uncontrolled hypercalcemia
- Uncontrolled hypomagnesemia or hypokalemia
- Leptomeningeal disease as a manifestation of cancer
- 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
- Untreated or active central nervous system (CNS) metastases
- Need for current chronic corticosteroid therapy (>/= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids for > 7 days) or use of other immunosuppressants
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442090
Locations
| United States, Florida | |
| Fort Myers, Florida, United States, 33908 | |
| Saint Petersburg, Florida, United States, 33705 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89148 | |
| United States, New York | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37203 | |
| France | |
| Bordeaux, France, 33075 | |
| Paris, France, 75908 | |
| Villejuif, France, 94800 | |
| Germany | |
| Berlin, Germany, 10117 | |
| Hannover, Germany, 30625 | |
| München, Germany, 81377 | |
| Spain | |
| Barcelona, Spain, 08003 | |
| Barcelona, Spain, 08035 | |
| Madrid, Spain, 28041 | |
| United Kingdom | |
| Leeds, United Kingdom, LS9 7TF | |
| London, United Kingdom, EC1M 6BQ | |
| London, United Kingdom, SW3 6JJ | |
| Manchester, United Kingdom, M20 4BX | |
| Sutton, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01442090 History of Changes |
| Other Study ID Numbers: | PIM4973g, GO00885 |
| Study First Received: | September 26, 2011 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Everolimus |
Sirolimus Endothelial Growth Factors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Growth Substances |
ClinicalTrials.gov processed this record on June 18, 2013