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Active (not recruiting) Phase 1 NCT04449874

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

Phase 1 – testing safety in a small group of people
Conditions: Non-Small Cell Lung Cancer Colorectal Cancer Advanced Solid Tumors

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 17
Australia (1)
St Vincent's Hospital Sydney
Darlinghurst , New South Wales
Belgium (1)
UZ Antwerpen
Edegem
Brazil (1)
Santa Casa de Misericordia de Belo Horizonte - PPDS
Belo Horizonte , Minas Gerais
Canada (1)
Ottawa Hospital
Ottawa , Ontario
Hungary (1)
Clinexpert Gyongyos Kft
Gyöngyös
Israel (1)
Rambam Medical Center
Haifa
Italy (1)
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola , Emilia-Romagna
Kenya (1)
The Aga Khan University-Kenya.
Nairobi
Netherlands (1)
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam
New Zealand (1)
Auckland City Hospital, Cancer and Blood Research
Auckland
Norway (1)
Haukeland University Hospital
Bergen
Poland (1)
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
Gdansk
South Korea (1)
Seoul National University Bundang Hospital
Seongnam-si
Spain (1)
Hospital Universitari Vall d'Hebron
Barcelona
Switzerland (1)
Inselspital
Bern
United Kingdom (1)
Queen Elizabeth Hospital
Birmingham
United States (1)
City of Hope Comprehensive Cancer Center
Duarte , California
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
29.07.2020
Completion date
31.12.2027
Registry ID
NCT04449874
Source
anzctr
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