June 24, 2020
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June 29, 2020
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May 17, 2024
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July 29, 2020
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November 30, 2024 (Final data collection date for primary outcome measure)
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- Percentage of Participants With Adverse Events (AEs) [ Time Frame: From baseline up until 28 days after the final dose ]
- Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Days 1-21 of Cycle 1 (a cycle is 21 days) ]
- Percentage of Participants With Changes From Baseline in Targeted Vital Signs [ Time Frame: From baseline up until 28 days after the final dose ]
- Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results [ Time Frame: From baseline up until 28 days after the final dose ]
- Percentage of Participants With Changes From Baseline in Targeted ECG Parameters [ Time Frame: From baseline up until 28 days after the final dose ]
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- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
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- Plasma Concentration of GDC-6036 [ Time Frame: From baseline up until 28 days after the final dose or at study treatment discontinuation visit ]
- 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: Up to 42 months ]
- Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: Up to 42 months ]
- Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: Up to 42 months ]
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Not Provided
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Not Provided
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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
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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
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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.
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Not Provided
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Interventional
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Phase 1
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Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment
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- Non-Small Cell Lung Cancer
- Colorectal Cancer
- Advanced Solid Tumors
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- Drug: GDC-6036
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).
- Drug: Atezolizumab
A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
- Drug: Cetuximab
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.
- Drug: Bevacizumab
A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
- Drug: Erlotinib
150 mg of erlotinib will be administered PO QD in 21 day cycles.
- Drug: GDC-1971
The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
- Drug: Inavolisib
The starting dose of inavolisib will be determined from its single-agent dose escalation.
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- Experimental: Arm A: 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 study-specific threshold is reached.
Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.
Intervention: Drug: GDC-6036
- Experimental: Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab.
Interventions:
- Drug: GDC-6036
- Drug: Atezolizumab
- Experimental: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.
Interventions:
- Drug: GDC-6036
- Drug: Cetuximab
- Experimental: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.
Interventions:
- Drug: GDC-6036
- Drug: Bevacizumab
- Experimental: Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib.
Interventions:
- Drug: GDC-6036
- Drug: Erlotinib
- Experimental: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
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.
Interventions:
- Drug: GDC-6036
- Drug: GDC-1971
- Experimental: Arm G: GDC-6036 + Inavolisib (Stage I and 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.
Interventions:
- Drug: GDC-6036
- Drug: Inavolisib
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Not Provided
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Recruiting
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498
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108
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November 30, 2024
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November 30, 2024 (Final data collection date for primary outcome measure)
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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.
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Australia, Belgium, Brazil, Canada, Germany, Hungary, Israel, Italy, Kenya, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States
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France
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NCT04449874
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GO42144 2020-000084-22 ( EudraCT Number ) 2023-506311-18-00 ( Other Identifier: EU CT Number )
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No
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Plan to Share IPD: |
No |
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). |
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Genentech, Inc.
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Same as current
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Genentech, Inc.
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Same as current
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Not Provided
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Study Director: |
Clinical Trials |
Genentech, Inc. |
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Genentech, Inc.
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May 2024
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