FAST LANE
10 Dec 2020
Trial Summary
Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Acronym:
CodeBreak 100
ACTRN/NCT /ethics:
NCT03600883
Scientific title:
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced Solid Tumors
Sponsor / Cooperative group:
Amgen
Trial & Patient Characteristics
| Cancer Type | All cancers |
|---|---|
| Trial Type | Treatment |
| Phase | Phase I; Phase II |
| Age Range | 18 years and older |
| Sex | Both |
| Tumour Stream | Advanced Solid Tumors |
| Cancer Stage | Locally Recurrent or Locally Advanced; Metastatic or Widespread |
| Anticipated Start Date | 2018-08-27 |
| Anticipated End Date | 2024-03-08 |
Participating Hospitals
| Hospital | The Queen Elizabeth Hospital |
|---|---|
| Clinical Trial Coordinator | Pamela Cooper |
| pamela.cooper@sa.gov.au | |
| Phone | 08 8222 6410 |
| Principal Investigator | Professor Tim Price |
| Recruitment Status | Recruiting |