Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

Status Completed

Clinical Trial Summary

This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Colorectal Neoplasms
Metastatic Colorectal Adenocarcinoma

Clinical Trial Details

NCT number	NCT03043313
Study type	Interventional
Source	Seagen Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	June 23, 2017
Completion date	November 2, 2023

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT01639131` - Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma	Phase 2
Not yet recruiting	`NCT05356897` - Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study	Phase 2
Recruiting	`NCT06102902` - Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer	Phase 1
Completed	`NCT05869097` - Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy in Refractory Metastatic Colorectal Cancer
Recruiting	`NCT05627635` - FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer	Phase 1/Phase 2
Active, not recruiting	`NCT04362839` - Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer	Phase 1
Recruiting	`NCT05672316` - Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy	Phase 1/Phase 2
Recruiting	`NCT02600949` - Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer	Phase 1
Active, not recruiting	`NCT04117945` - Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer	Phase 2
Recruiting	`NCT04511039` - Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer	Phase 1
Recruiting	`NCT04483219` - Tyrosine Kinase Inhibitor (TKI) + Anti-PD-1 Antibody in TKI-responded Microsatellite Stability/Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Adenocarcinoma.	Phase 2
Completed	`NCT01900717` - Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)	Phase 2
Active, not recruiting	`NCT05312398` - CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen	Phase 2
Completed	`NCT05942768` - Anti-PD-1 Antibody Plus Regorafenib in Refractory Microsatellite Stable Metastatic Colorectal Cancer
Completed	`NCT06031376` - Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC
Not yet recruiting	`NCT06195670` - Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC	Phase 1/Phase 2
Recruiting	`NCT02997228` - Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study	Phase 3
Recruiting	`NCT05673148` - Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study	Phase 3
Completed	`NCT05130060` - A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer	Phase 1
Completed	`NCT06083974` - Metastatic Left Colon and Rectal Cancer Treatment With Anti_EGFR Targeted Therapy