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NCT02560779 · ClinicalTrials.gov registry record · Phase 1
Trial of TRC105 and Sorafenib in Patients With HCC
A Phase 1 study, sponsored by Tracon Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02560779: Completed Phase 1 study, sponsored by Tracon Pharmaceuticals.
NCT02560779 is a Phase 1 study that has completed, run by Tracon Pharmaceuticals. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02560779, a Phase 1 study, has completed, sponsored by Tracon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma. Up to 18 patients will be treated. The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.
Primary Outcome
If 1 of 3 patients experienced a DLT, the dose level was expanded to 6 patients. The maximum tolerated dose (MTD) would have been exceeded if ≥ 33% of patients experience DLT at a given dose level. DLT occurred when a patient had 1 or more toxicities outlined in the protocol that was considered at least possibly related to TRC105 during the first 4 months of participation in the trial. The number of DLTs by dose cohort have been presented.
Interventions
- DRUG Sorafenib
- DRUG Carotuximab (TRC105)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-08 |
| Phase | Phase 1 |
What the finished NCT02560779 record still lists
NCT02560779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT02560779 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02560779 about?
NCT02560779 is a clinical study titled "Trial of TRC105 and Sorafenib in Patients With HCC". The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma. Up to 18 patients will be treated. The purpose of the phase 2 portion is to estimate the OR...
What is the current status of trial NCT02560779?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2016-11. Estimated completion is 2019-08.
What interventions are being tested in trial NCT02560779?
The interventions under investigation include: Sorafenib (DRUG), Carotuximab (TRC105) (DRUG).
Who is sponsoring clinical trial NCT02560779?
This trial is sponsored by Tracon Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02560779's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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