| Title |
An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer |
| Protocole ID |
MOUNTAINEER-03 |
| ClinicalTrials.gov ID |
NCT05253651 |
| Cancer Type(s) |
Colon and Rectum |
| Phase |
Phase III |
| Stage |
Metastatic |
| Study Type |
Clinical |
| Drug |
Tucatinib en association avec trastuzumab et mFOLFOX6 versus mFOLFOX6 avec ou sans cétuximab ou bévacizumab |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| City |
|
| Principal Investigator |
Dr. Petr Kavan
|
| Coordinator |
Oleg Lapsin
514-340-8222 poste 28437
|
| Status |
Recruiting |
| Activation Date |
23-01-2023 |
| Eligibility Criteria |
- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is metastatic and/or unresectable
-
Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory
- If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
- HER2+ disease as determined by a tissue based assay performed at a central laboratory.
- Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing
-
Radiographically measurable disease per RECIST v1.1 with:
- At least one site of disease that is measurable and that has not been previously irradiated, or
- If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-
CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:
- No evidence of brain metastases
- Previously treated brain metastases which are asymptomatic
|
| Exclusion Criteria |
-
Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting
- May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
- Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
- Previous treatment with anti-HER2 therapy
- Ongoing Grade 3 or higher neuropathy
- GI perforation within 12 months of enrollment
|
| |
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Groupe d'étude en oncologie du Québec