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NCT04430738 · ClinicalTrials.gov registry record · Phase 2
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
A Phase 2 study of Cholangiocarcinoma and Colorectal Carcinoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 20
- Study locations
NCT04430738: Active Phase 2 study of Cholangiocarcinoma and Colorectal Carcinoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
NCT04430738 is a Phase 2 study of Cholangiocarcinoma and Colorectal Carcinoma that is active but no longer recruiting, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 40 participants, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04430738, a Phase 2 study of Cholangiocarcinoma and Colorectal Carcinoma, is active but no longer recruiting, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).
Primary Outcome
A renal DLT was defined as an increase in serum cystatin C \>1.5\* baseline that was not related to pre-renal or post-renal etiologies (including disease progression, dehydration and intercurrent illness) and occurred during the period of treatment with tucatinib in combination with trastuzumab and FOLFOX between the first dose of tucatinib and the end of Cycle 3. Increased serum cystatin C for which there was an alternative clinical explanation (eg, clearly related to an intercurrent illness or
Conditions Studied
Interventions
- DRUG tucatinib
- DRUG trastuzumab
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin
Study Locations (20)
Missouri
- Siteman Cancer Center - St Peters - City of Saint Peters
- Siteman Cancer Center - West County - Creve Coeur
- Siteman Cancer Center - North County - Florissant
- Siteman Cancer Center - St Louis
- Barnes-Jewish Hospital - St Louis
- Washington University School of Medicine - St Louis
- Siteman Cancer Center - South County - St Louis
Colorado
- University of Colorado Denver CTO(CTRC) - Aurora
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) - Aurora
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) - Aurora
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) - Aurora
- PCM Trials - Denver
Arizona
- Mayo Clinic Hospital - Phoenix
- Mayo Clinic - Scottsdale
North Carolina
- Duke University Medical Center, Duke Cancer Center - Durham
- Duke University Medical Center - Durham
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
New Mexico
- University of New Mexico Comprehensive Cancer Center - Albuquerque
Ohio
- Cleveland Clinic - Cleveland
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04430738 still lists
NCT04430738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (90% lower).
The record links to 6 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which tucatinib is the first listed.
NCT04430738 names 20 study sites across 8 states, led by Missouri, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT04430738 about?
NCT04430738 is a clinical study titled "Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers". This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating ca...
What is the current status of trial NCT04430738?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-09-15. Estimated completion is 2026-12-31.
What conditions does trial NCT04430738 study?
This clinical trial studies the following conditions: Cholangiocarcinoma, Colorectal Carcinoma, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Gallbladder Carcinoma.
What interventions are being tested in trial NCT04430738?
The interventions under investigation include: tucatinib (DRUG), trastuzumab (DRUG), oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin (DRUG).
Who is sponsoring clinical trial NCT04430738?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04430738 being conducted?
This trial has 20 study locations across Arizona, Colorado, District of Columbia, Missouri, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cholangiocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04430738's enrollment target sits among peer trials
40 43rd of 60 higher than 17 of 60 other Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cholangiocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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