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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04449874




Registration number
NCT04449874
Ethics application status
Date submitted
24/06/2020
Date registered
29/06/2020
Date last updated
19/10/2020

Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Scientific title
A Phase I Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Secondary ID [1] 0 0
2020-000084-22
Secondary ID [2] 0 0
GO42144
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Colorectal Cancer 0 0
Advanced Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GDC-6036

Experimental: Dose-escalation (Stage I), Dose Expansion (Stage II) - Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a safety threshold is observed.
Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.


Treatment: Drugs: GDC-6036
Stage I and Stage II: GDC-6036 will be administered PO QD.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From baseline up until 28 days after the final dose
Primary outcome [2] 0 0
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Days 1-21 of Cycle 1 (a cycle is 21 days)
Primary outcome [3] 0 0
Percentage of Participants With Changes From Baseline in Targeted Vital Signs
Timepoint [3] 0 0
From baseline up until 28 days after the final dose
Primary outcome [4] 0 0
Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results
Timepoint [4] 0 0
From baseline up until 28 days after the final dose
Primary outcome [5] 0 0
Percentage of Participants With Changes From Baseline in Targeted ECG Parameters
Timepoint [5] 0 0
From baseline up until 28 days after the final dose
Secondary outcome [1] 0 0
Plasma Concentration of GDC-6036
Timepoint [1] 0 0
From baseline up until 28 days after the final dose or at study treatment discontinuation visit
Secondary outcome [2] 0 0
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [2] 0 0
Up to 42 months
Secondary outcome [3] 0 0
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [3] 0 0
Up to 42 months
Secondary outcome [4] 0 0
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [4] 0 0
Up to 42 months

Eligibility
Key inclusion criteria
- Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active brain metastases

- Malabsorption or other condition that interferes with enteral absorption

- Clinically significant cardiovascular dysfunction or liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - East Melbourne
Recruitment hospital [2] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Belgium
State/province [8] 0 0
Edegem
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
France
State/province [11] 0 0
Dijon
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Rennes
Country [15] 0 0
France
State/province [15] 0 0
Toulouse
Country [16] 0 0
France
State/province [16] 0 0
Villejuif
Country [17] 0 0
Germany
State/province [17] 0 0
Dresden
Country [18] 0 0
Germany
State/province [18] 0 0
Köln
Country [19] 0 0
Italy
State/province [19] 0 0
Emilia-Romagna
Country [20] 0 0
Italy
State/province [20] 0 0
Lombardia
Country [21] 0 0
Netherlands
State/province [21] 0 0
Amsterdam
Country [22] 0 0
Netherlands
State/province [22] 0 0
Utrecht
Country [23] 0 0
Poland
State/province [23] 0 0
Gdansk
Country [24] 0 0
Poland
State/province [24] 0 0
Jozefow
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Moskovskaja Oblast
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Kazan
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
Sevilla
Country [29] 0 0
Switzerland
State/province [29] 0 0
Basel
Country [30] 0 0
Switzerland
State/province [30] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04449874
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GO42144 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04449874