Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreaK 101)

JRCT ID: jRCT2031210121

Registered date:28/05/2021

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

- Advanced Solid Tumors
- Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

• Date of first enrollment: 17/12/2019
• Target sample size: 1143
• Countries of recruitment: United States,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,Germany,Japan,Italy,Japan,Korea,Japan,Netherlands,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

- Experimental: Sotorasib + panitumumab +/- FOLFIRI
Experimental: Sotorasib + panitumumab +/- FOLFIRI Dose Exploration and Dose Expansion
-Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
-Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Interventions:
-Drug: Sotorasib
-Drug: panitumumab
-Drug: FOLFIRI

Outcome(s)

Primary Outcome

1. Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 12 Months ]
2. Phase 1b: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 Months ]
3. Phase 1b: Number of Participants with Treatment-related Adverse Events [ Time Frame: 12 Months ]
4. Phase 1b: Number of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: 12 Months ]
5. Phase 1b: Number of Participants with Clinically Significant Changes in ECG Measurements [ Time Frame: 12 Months ]
6. Phase 1b: Number of Participants with Clinically Significant Changes in Laboratory Test Values [ Time Frame: 12 Months ]
7. Phase 2: Objective Response Rate [ Time Frame: 12 Months ]

Secondary Outcome

1. Phase 1b: Maximum Plasma Concentration (Cmax) [ Time Frame: 12 Months ]
2. Phase 1b: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 12 Months ]
3. Phase 1b: Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 12 Months ]
4. Phase 1b: Objective Response Rate [ Time Frame: 12 Months ]
5. Phase 1b: Disease Control Rate [ Time Frame: 12 Months ]
6. Phase 1b: Duration of Response [ Time Frame: 12 Months ]
7. Phase 1b: Progression-free Survival [ Time Frame: 12 Months ]
8. Phase 1b: Duration of Stable Disease [ Time Frame: 12 Months ]
9. Phase 1b: Time to Response [ Time Frame: 12 Months ]
10. Phase 1b: Overall Survival [ Time Frame: 12 Months ]
11. Phase 1b: Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels [ Time Frame: 12 Months ]
12. Phase 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 Months ]
13. Phase 2: Number of Participants with Grade >=3 Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 Months ]
14. Phase 2: Maximum Plasma Concentration (Cmax) [ Time Frame: 12 Months ]
15. Phase 2: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 12 Months ]
16. Phase 2: Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 12 Months ]
17. Phase 2: Disease Control Rate [ Time Frame: 12 Months ]
18. Phase 2: Duration of Response [ Time Frame: 12 Months ]
19. Phase 2: Progression-free Survival [ Time Frame: 12 Months ]
20. Phase 2: Time to Response [ Time Frame: 12 Months ]
21. Phase 2: Overall Survival [ Time Frame: 12 Months ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 100age old
• Gender: Both

Include criteria

- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclude criteria

- Primary brain tumor.
- Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Related Information

• Primary Sponsor: Nakatani iwami
• Secondary ID(s): NCT04185883