MyPathway
My Pathway: An Open-Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents
Phase 2N = 57NCT02091141
- Population
- Treatment-refractory, histologically confirmed HER2-amplified metastatic colorectal cancer with measurable or evaluable disease
- Design
- Ongoing multiple-basket phase 2a study; this record covers the subset of patients with treatment-refractory HER2-amplified metastatic colorectal cancer who received pertuzumab (840 mg loading dose, then 420 mg every 3 weeks) plus trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks) at 25 hospitals or clinics in 16 US states. The primary endpoint was the proportion of patients with an objective response based on investigator-reported tumour responses.
- Primary endpoint
- ORR
- Arms
- Pertuzumab + trastuzumab (experimental, n = 57): Pertuzumab plus trastuzumab
- People
- Meric-Bernstam F
Show the numbers
| Endpoint | Analysis | Pertuzumab + trastuzumab | Control | Effect |
|---|---|---|---|---|
| ORR57 evaluable patients with HER2-amplified metastatic colorectal cancerObjective response, investigator-reported (primary endpoint) | primaryMeric-Bernstam 2019 | 32% (20–45%) | — | Eighteen of 57 patients responded (one complete and 17 partial responses) as of 1 August 2017. Single-arm basket cohort. |
| Endpoint | Analysis | Pertuzumab + trastuzumab | Control | Effect |
|---|---|---|---|---|
| ORR57 evaluable patients with HER2-amplified metastatic colorectal cancerObjective response, investigator-reported (primary endpoint) | primaryMeric-Bernstam 2019 | 32% (20–45%) | — | Eighteen of 57 patients responded (one complete and 17 partial responses) as of 1 August 2017. Single-arm basket cohort. |
Appears in
Sources
Meric-Bernstam F, Hurwitz H, Raghav KPS, McWilliams RR, Fakih M, VanderWalde A, et al. Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2019;20(4):518-530.