Breast Cancer Clinical Trial

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Summary

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study treatment as specified in the protocol.
Men who are not surgically sterile must agree to remain abstinent or use a condom, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.

Exclusion Criteria:

Active brain metastases.
Malabsorption or other condition that interferes with enteral absorption.
Clinically significant cardiovascular dysfunction or liver disease.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

498

Study ID:

NCT04449874

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 60 Locations for this study

See Locations Near You

City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
UCSD Moores Cancer Center
La Jolla California, 92093, United States
Chao Family Comprehensive Cancer Center UCI
Orange California, 92868, United States
Univ of Calif, San Francisco; Breast Cancer Center
San Francisco California, 94115, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
Florida Cancer Specialists - Sarasota
Sarasota Florida, 34232, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Oklahoma; Stephenson Oklahoma Canc Ctr
Oklahoma City Oklahoma, 73104, United States
Abramson Cancer Center; Univ of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
UPMC - Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
St Vincent's Hospital Sydney
Darlinghurst New South Wales, 2010, Australia
Alfred Health
Melbourne Victoria, 3004, Australia
Peter MacCallum Cancer Center
North Melbourne Victoria, 3051, Australia
Linear Clinical Research Limited
Nedlands Western Australia, 6009, Australia
UZ Antwerpen
Edegem , 2650, Belgium
CHU de Liège
Herstal , 4040, Belgium
AZ St Maarten Campus Leopoldstr
Mechelen , 2800, Belgium
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
Sao Jose Do Rio Preto SP, 15090, Brazil
Ottawa Hospital
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 1, Canada
Jewish General Hospital; Sir Mortimer B. Davis
Montreal Quebec, H2W 1, Canada
Rambam Medical Center
Haifa , 31096, Israel
Sheba Medical Center - PPDS
Ramat-Gan , 52620, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola Emilia-Romagna, 47014, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milano Lombardia, 20132, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milano Lombardia, 20162, Italy
Istituto Clinico Humanitas
Rozzano (MI) Lombardia, 20089, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa Toscana, 56100, Italy
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center - PPDS
Seoul , 05505, Korea, Republic of
Samsung Medical Center - PPDS
Seoul , 06351, Korea, Republic of
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Leids Universitair Medisch Centrum
Leiden , 2333 , Netherlands
Maastricht University Medical Center
Maastricht , 6229 , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , 3584 , Netherlands
Auckland City Hospital
Auckland , 1023, New Zealand
New Zealand Clinical Research - Christchurch
Christchurch , 8011, New Zealand
Haukeland University Hospital; Hospital Pharmacy
Bergen , 5053, Norway
Oslo university hospital Radiumhospitalet
Oslo , 0424, Norway
Medical University of Gdansk
Gdansk , 80-95, Poland
Biokinetica, Przychodnia Jozefow
Jozefow , 05-41, Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.
Poznań , 60-78, Poland
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan Tatarstan, 42002, Russian Federation
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid , 28050, Spain
Hospital Clinico Universitario Virgen de la Victoria
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Universitaetsspital Basel; Onkologie
Basel , 4031, Switzerland
Inselspital
Bern , 3010, Switzerland
Hôpitaux Universitaires de Genève
Genève , 1211, Switzerland
Unversitätsspital Zürich
Zürich , 8091, Switzerland
Velindre Cancer Centre
Cardiff , CF14 , United Kingdom
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility
London , W1T 7, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

498

Study ID:

NCT04449874

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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