Clinical trial · no report yet · Phase 2
ACCRU-GI-1617
Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
- NCT03043313 ↗
- Completed
- Seagen Inc.
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| Podcasts | 70 | |
| X threads | 57 | |
| YouTube | 48 | |
| Bluesky threads | 1 |
The trial
ClinicalTrials.gov- Official title
- MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer
- Phase
- Phase 2
- Status
- Completed
- Conditions
- Metastatic Colorectal Adenocarcinoma
- Interventions
- Trastuzumab; Tucatinib
- Arms
- Cohort A: Tucatinib + Trastuzumab · Experimental
- Cohort B: Tucatinib + Trastuzumab · Experimental
- Cohort C: Tucatinib Monotherapy · Experimental
- Enrollment
- 117
- Primary outcomes
- Confirmed Objective Response Rate (cORR) Per RECIST v1.1 Per Blinded Independent Central Review (BICR) in Pooled Cohorts A+B
- Sponsor
- Seagen Inc. with National Cancer Institute (NCI), Academic and Community Cancer Research United
- Start
- Jun 23, 2017
- Primary completion
- Mar 28, 2022
- Results posted
- Yes
- Registry record
- NCT03043313 · updated Nov 26, 2024
Publications
linked from the registry- Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5. PubMed 39368039
- Strickler JH, Bekaii-Saab TS. A study to learn how well tucatinib plus trastuzumab works for treating participants with metastatic colorectal cancer, and how safe it is: a plain language summary of the MOUNTAINEER study. Future Oncol. 2024 Mar;20(8):409-421. doi: 10.2217/fon-2023-0676. Epub 2023 Nov 8. PubMed 37941353
- Casak SJ, Horiba MN, Yuan M, Cheng J, Lemery SJ, Shen YL, Fu W, Moore JN, Li Y, Bi Y, Auth D, Fesenko N, Kluetz PG, Pazdur R, Fashoyin-Aje LA. FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer. Clin Cancer Res. 2023 Nov 1;29(21):4326-4330. doi: 10.1158/1078-0432.CCR-23-1041. PubMed 37318379
- Strickler JH, Cercek A, Siena S, Andre T, Ng K, Van Cutsem E, Wu C, Paulson AS, Hubbard JM, Coveler AL, Fountzilas C, Kardosh A, Kasi PM, Lenz HJ, Ciombor KK, Elez E, Bajor DL, Cremolini C, Sanchez F, Stecher M, Feng W, Bekaii-Saab TS; MOUNTAINEER investigators. Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER): a multicentre, open-label, phase 2 study. Lancet Oncol. 2023 May;24(5):496-508. doi: 10.1016/S1470-2045(23)00150-X. PubMed 37142372