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:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01442090
First received: September 26, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

Study PIM4973g is a multicenter, international, open-label Phase II trial. Pati ents with metastatic renal cell carcinoma who have progressed on or after Vascu lar 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
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 12, 2014
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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Growth Substances

ClinicalTrials.gov processed this record on August 21, 2014