search
Back to results

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

Primary Purpose

Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GDC-6036
Atezolizumab
Cetuximab
Bevacizumab
Erlotinib
GDC-1971
Inavolisib
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring KRAS G12C, Non-Small Cell Lung Cancer, Colorectal Cancer, GDC-6036, Metastatic Solid Tumor, Atezolizumab, Bevacizumab, Cetuximab, Erlotinib, Inavolisib, GDC-1971, SHP2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope Comprehensive Cancer CenterRecruiting
  • UCSD Moores Cancer CenterRecruiting
  • Chao Family Comprehensive Cancer Center UCIRecruiting
  • Univ of Calif, San Francisco; Breast Cancer CenterRecruiting
  • Yale Cancer CenterRecruiting
  • Florida Cancer Specialists - SarasotaRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of Oklahoma; Stephenson Oklahoma Canc CtrRecruiting
  • Abramson Cancer Center; Univ of PennsylvaniaRecruiting
  • UPMC - Hillman Cancer CenterRecruiting
  • St Vincent's Hospital SydneyRecruiting
  • Slade Health Inward goodsRecruiting
  • Alfred HealthRecruiting
  • Peter MacCallum Cancer CenterRecruiting
  • Linear Clinical Research LimitedRecruiting
  • UZ AntwerpenRecruiting
  • CHU de LiègeRecruiting
  • AZ St Maarten Campus LeopoldstrRecruiting
  • Santa Casa de Misericórdia de Belo Horizonte - PPDSRecruiting
  • Hospital de Clinicas de Porto Alegre HCPA PPDSRecruiting
  • Hospital Erasto GaertnerRecruiting
  • Instituto Nacional de CâncerRecruiting
  • Universidade de Caxias do SulRecruiting
  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)Recruiting
  • Hospital de Cancer de BarretosRecruiting
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDSRecruiting
  • Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
  • Ottawa HospitalRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • Jewish General Hospital; Sir Mortimer B. DavisRecruiting
  • Semmelweis EgyetemRecruiting
  • Clinexpert Kft. - GyongyosRecruiting
  • Rambam Medical CenterRecruiting
  • Sheba Medical Center - PPDSRecruiting
  • Tel-Aviv Sourasky Medical CenterRecruiting
  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
  • Irccs Ospedale San Raffaele;Oncologia MedicaRecruiting
  • Asst Grande Ospedale Metropolitano NiguardaRecruiting
  • Istituto Clinico HumanitasRecruiting
  • Azienda Ospedaliero Universitaria PisanaRecruiting
  • Aga Khan University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical Center - PPDSRecruiting
  • Samsung Medical Center - PPDSRecruiting
  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek ZiekenhuisRecruiting
  • Leids Universitair Medisch CentrumRecruiting
  • Maastricht University Medical CenterRecruiting
  • Universitair Medisch Centrum UtrechtRecruiting
  • Auckland City Hospital, Cancer and Blood ResearchRecruiting
  • Auckland City HospitalRecruiting
  • New Zealand Clinical Research - ChristchurchRecruiting
  • Haukeland University Hospital; Hospital PharmacyRecruiting
  • Oslo university hospital RadiumhospitaletRecruiting
  • Medical University of GdanskRecruiting
  • Biokinetica, Przychodnia JozefowRecruiting
  • Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
  • Hospital Universitari Vall d'HebronRecruiting
  • START Madrid-FJD, Hospital Fundacion Jimenez DiazRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario HM Sanchinarro-CIOCCRecruiting
  • Hospital Clinico Universitario Virgen de la VictoriaRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Universitaetsspital Basel; Onkologie
  • InselspitalRecruiting
  • Hôpitaux Universitaires de GenèveRecruiting
  • Unversitätsspital Zürich
  • Queen Elizabeth HospitalRecruiting
  • Velindre Cancer CentreRecruiting
  • University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research FacilityRecruiting
  • The Christie NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)

Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)

Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)

Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)

Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)

Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)

Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)

Arm Description

Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached. Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.

Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab.

Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.

Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.

Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib.

Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II.

Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events (AEs)
Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Percentage of Participants With Dose-Limiting Toxicities (DLTs)

Secondary Outcome Measures

Plasma Concentrations of GDC-6036
Plasma Concentrations of Erlotinib
Plasma Concentrations of GDC-1971
Plasma Concentrations of Inavolisib
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Progression-free survival (PFS) as determined by the investigator according to RECIST v1.1
Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax])
Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax])
Relationship Between GDC-6036 Exposure (Half-life [t1/2])
Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC])
Relationship Between Tumor Pharmacodynamic Effects of GDC-6036

Full Information

First Posted
June 24, 2020
Last Updated
October 12, 2023
Sponsor
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04449874
Brief Title
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
Official Title
A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors
Keywords
KRAS G12C, Non-Small Cell Lung Cancer, Colorectal Cancer, GDC-6036, Metastatic Solid Tumor, Atezolizumab, Bevacizumab, Cetuximab, Erlotinib, Inavolisib, GDC-1971, SHP2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
498 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)
Arm Type
Experimental
Arm Description
Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached. Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.
Arm Title
Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
Arm Type
Experimental
Arm Description
Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab.
Arm Title
Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
Arm Type
Experimental
Arm Description
Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.
Arm Title
Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
Arm Type
Experimental
Arm Description
Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.
Arm Title
Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
Arm Type
Experimental
Arm Description
Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib.
Arm Title
Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
Arm Type
Experimental
Arm Description
Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II.
Arm Title
Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)
Arm Type
Experimental
Arm Description
Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II.
Intervention Type
Drug
Intervention Name(s)
GDC-6036
Intervention Description
The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m^2) IV infusion followed by 250 mg/m^2 IV infusion weekly in 21 day cycles.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
150 mg of erlotinib will be administered PO QD in 21 day cycles.
Intervention Type
Drug
Intervention Name(s)
GDC-1971
Intervention Description
The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
Intervention Type
Drug
Intervention Name(s)
Inavolisib
Intervention Description
The starting dose of inavolisib will be determined from its single-agent dose escalation.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs)
Description
Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time Frame
From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.
Title
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Time Frame
From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
Secondary Outcome Measure Information:
Title
Plasma Concentrations of GDC-6036
Time Frame
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Plasma Concentrations of Erlotinib
Time Frame
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Plasma Concentrations of GDC-1971
Time Frame
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Plasma Concentrations of Inavolisib
Time Frame
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame
Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Time Frame
Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Progression-free survival (PFS) as determined by the investigator according to RECIST v1.1
Time Frame
Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax])
Time Frame
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax])
Time Frame
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Relationship Between GDC-6036 Exposure (Half-life [t1/2])
Time Frame
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC])
Time Frame
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Title
Relationship Between Tumor Pharmacodynamic Effects of GDC-6036
Time Frame
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GO42144 whttps://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
Chao Family Comprehensive Cancer Center UCI
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Univ of Calif, San Francisco; Breast Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists - Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Oklahoma; Stephenson Oklahoma Canc Ctr
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Abramson Cancer Center; Univ of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
UPMC - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Slade Health Inward goods
City
Mount Kuring-gai
State/Province
New South Wales
ZIP/Postal Code
2080
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Center
City
North Melbourne
State/Province
Victoria
ZIP/Postal Code
3051
Country
Australia
Individual Site Status
Recruiting
Facility Name
Linear Clinical Research Limited
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ St Maarten Campus Leopoldstr
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Santa Casa de Misericórdia de Belo Horizonte - PPDS
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Clinicas de Porto Alegre HCPA PPDS
City
Porto Alegre
State/Province
PA
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Erasto Gaertner
City
Curitiba
State/Province
PR
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Câncer
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20230-130
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Universidade de Caxias do Sul
City
Caxias Do Sul
State/Province
RS
ZIP/Postal Code
95070-561
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
City
Sao Jose Do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Jewish General Hospital; Sir Mortimer B. Davis
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinexpert Kft. - Gyongyos
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center - PPDS
City
Ramat-Gan
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Irccs Ospedale San Raffaele;Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Asst Grande Ospedale Metropolitano Niguarda
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aga Khan University Hospital
City
Nairobi
ZIP/Postal Code
00100
Country
Kenya
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center - PPDS
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Auckland City Hospital, Cancer and Blood Research
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
New Zealand Clinical Research - Christchurch
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Haukeland University Hospital; Hospital Pharmacy
City
Bergen
ZIP/Postal Code
5053
Country
Norway
Individual Site Status
Recruiting
Facility Name
Oslo university hospital Radiumhospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Biokinetica, Przychodnia Jozefow
City
Jozefow
ZIP/Postal Code
05-410
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Pozna?
ZIP/Postal Code
60-780
Country
Poland
Individual Site Status
Recruiting
Facility Name
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro-CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Universitaetsspital Basel; Onkologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Withdrawn
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Hôpitaux Universitaires de Genève
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Unversitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Withdrawn
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this 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

We'll reach out to this number within 24 hrs