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NCT02375880 · ClinicalTrials.gov registry record · Phase 1
Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder
A Phase 1 study, sponsored by Leap Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT02375880: Completed Phase 1 study, sponsored by Leap Therapeutics.
NCT02375880 is a Phase 1 study that has completed, run by Leap Therapeutics. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02375880, a Phase 1 study, has completed, sponsored by Leap Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
DKN-01 is a humanized monoclonal antibody (Mab) with neutralizing activity against Dkk-1 and is being developed as an anti-neoplastic agent. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of DKN-01 in combination with gemcitabine and cisplatin in patients with carcinoma primary to the intra- or exta-hepatic biliary system or gallbladder.
Primary Outcome
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.03).
Interventions
- DRUG cisplatin
- DRUG gemcitabine
- DRUG DKN-01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2015-06 |
| Est. Completion | 2018-07 |
| Phase | Phase 1 |
What the finished NCT02375880 record still lists
NCT02375880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which cisplatin is the first listed.
NCT02375880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02375880 about?
NCT02375880 is a clinical study titled "Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder". DKN-01 is a humanized monoclonal antibody (Mab) with neutralizing activity against Dkk-1 and is being developed as an anti-neoplastic agent. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of DKN-01 in combination with gemcitabine and cisplatin ...
What is the current status of trial NCT02375880?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2015-06. Estimated completion is 2018-07.
What interventions are being tested in trial NCT02375880?
The interventions under investigation include: cisplatin (DRUG), gemcitabine (DRUG), DKN-01 (DRUG).
Who is sponsoring clinical trial NCT02375880?
This trial is sponsored by Leap Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02375880's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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