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NCT01806064 · ClinicalTrials.gov registry record · Phase 1
Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients Renal Cell Carcinoma
A Phase 1 study, sponsored by Tracon Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 173
- Enrollment target
NCT01806064: Clinical Trial Phase 1 study, sponsored by Tracon Pharmaceuticals.
NCT01806064 is a Phase 1 study that was terminated before completion, run by Tracon Pharmaceuticals. The registered enrollment target is 173 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01806064, a Phase 1 study, was terminated before completion, sponsored by Tracon Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 173 participants
- Enrollment target
Study Summary
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
Primary Outcome
Phase 1b: For dose limiting toxicity (DLT) evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0).
Interventions
- DRUG Axitinib
- DRUG TRC105 and Axitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2013-03-08 |
| Est. Completion | 2019-06-12 |
| Phase | Phase 1 |
Why NCT01806064 stopped before completion
NCT01806064 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (188% higher).
The record links to 0 conditions, and to 2 interventions - of which Axitinib is the first listed.
NCT01806064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01806064 about?
NCT01806064 is a clinical study titled "Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients Renal Cell Carcinoma". Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated ...
What is the current status of trial NCT01806064?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 173 participants. The study started on 2013-03-08. Estimated completion is 2019-06-12.
What interventions are being tested in trial NCT01806064?
The interventions under investigation include: Axitinib (DRUG), TRC105 and Axitinib (DRUG).
Who is sponsoring clinical trial NCT01806064?
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 NCT01806064's enrollment target sits among peer trials
173 324th of 2000 higher than 1,677 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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