A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
Completed · Phase 1
Conditions studied: Metastatic Colorectal Cancer
In brief
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal Cancer.
Key facts
- Study ID
- NCT03031691
- Run by
- OncoMed Pharmaceuticals, Inc.
- People needed
- 7
- Starts
- 2017-01-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2020-08-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy
- ECOG performance status 0 or 1
You may not qualify if…
- Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
- Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible
- Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug
- Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:
- Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)
- Active peptic ulcer disease
- Known intraluminal metastatic lesion(s) with risk of bleeding
Where it is running
- Denver — Denver, Colorado, United States
- Miami — Miami, Florida, United States
- Sarasota — Sarasota, Florida, United States
- Charleston — Charleston, South Carolina, United States
- Nashville — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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