metastatic HER2+breast cancer Colorectal cancer
Conditions
Interventions
Patient to be randomized 1:1 to the tucatinib experimental arm (tucatinib in combination with trastuzumab and mFOLFOX6) or to the control arm (mFOLFOX6 given with or without either bevacizumab or cetu
C000705452
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic -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 iss measureable 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 imaging, participants may have any of the following: - No evidence of brain metastases - Previouslly treated brain metastates which are asymptomatic
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) by blinded independent central review (BICR) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Confirmed objective response rate (cORR) by BICR per RECIST v1.1 PFS by investigator assessment per RECIST v1.1 cORR by investigator assessment per RECIST v1.1 Duration of response (DOR) by BICR per RECIST v1.1 DOR by investigator assessment per RECIST v1.1 Time to second progression or death Incidence of adverse events Incidence of dose alterations Trough concentration Change from baseline in European ORganization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score Time to meaningful change in EORTC QLQC30 score | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Korea, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed