Protocol #: 17-673
Status
Recruiting
Description
This phase II trial studies how well the HER2 inhibitor tucatinib (ONT-380, ARRY-380) works in combination with trastuzumab in treating patients with HER2-positive (HER2+) metastatic colorectal cancer (CRC). Tucatinib may stop the growth of tumor cells by blocking HER2, a receptor needed for cell growth in patients with HER2+ tumors. Trastuzumab is a form of ?targeted therapy? because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body?s immune system. Giving tucatinib and trastuzumab in combination may work better in treating patients with HER2+ metastatic CRC.
Condition
ERBB2 Gene Amplification
HER2/Neu Positive
KRAS wt Allele
Metastatic Colon Adenocarcinoma
Metastatic Colorectal Adenocarcinoma
Metastatic Rectal Adenocarcinoma
NRAS wt Allele
Recurrent Colorectal Carcinoma
Stage III Colon Cancer AJCC v7
Stage III Colorectal Cancer AJCC v7
Stage III Rectal Cancer AJCC v7
Stage IIIA Colon Cancer AJCC v7
Stage IIIA Colorectal Cancer AJCC v7
Stage IIIA Rectal Cancer AJCC v7
Stage IIIB Colon Cancer AJCC v7
Stage IIIB Colorectal Cancer AJCC v7
Stage IIIB Rectal Cancer AJCC v7
Stage IIIC Colon Cancer AJCC v7
Stage IIIC Colorectal Cancer AJCC v7
Stage IIIC Rectal Cancer AJCC v7
Stage IV Colon Cancer AJCC v7
Stage IV Colorectal Cancer AJCC v7
Stage IV Rectal Cancer AJCC v7
Stage IVA Colon Cancer AJCC v7
Stage IVA Colorectal Cancer AJCC v7
Stage IVA Rectal Cancer AJCC v7
Stage IVB Colon Cancer AJCC v7
Stage IVB Colorectal Cancer AJCC v7
Stage IVB Rectal Cancer AJCC v7
Unresectable Colon Adenocarcinoma
Unresectable Rectal Adenocarcinoma
Interventions
Trastuzumab
Tucatinib
Phase
Phase 2
Study Type
Interventional
Further Study Details
Primary Outcome:
Objective response rate
Secondary Outcome:
Clinical best response
Overall survival
Progression free survival
Duration of response
Incidence of adverse events of grade 2 and above
Estimated Enrollment
40
Study Start Date
June 23, 2017
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Seattle Genetics, Inc.
Information Provided By
Seattle Genetics, Inc.
Official Title
MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer
Clinicaltrials.gov Identifier
NCT03043313

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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