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NCT01975519 · ClinicalTrials.gov registry record · Phase 1
A Phase 1B Dose-escalation and Phase 2a Study of Carotuximab (TRC105) in Combination With Pazopanib in Patients With Advanced Soft Tissue Sarcoma
A Phase 1 study, sponsored by Tracon Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
NCT01975519: Completed Phase 1 study, sponsored by Tracon Pharmaceuticals.
NCT01975519 is a Phase 1 study that has completed, run by Tracon Pharmaceuticals. The registered enrollment target is 111 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01975519, a Phase 1 study, has completed, sponsored by Tracon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 111 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 pazopanib in patients with advanced soft tissue sarcoma. Up to 30 patients will be treated. The purpose of the phase 2 portion is to estimate the PFS of patients with advanced soft tissue sarcoma by RECIST 1.1 and estimate ORR in a separate cohort of patients with angiosarcoma by RECIST 1.1. Up to 89 patients will be treated in phase 2, including two cohorts of up to 13 patients with angiosarcoma.
Primary Outcome
For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for ≥ 5 days, febrile neutropenia (grade 4 neutropenia with fever \> 38.5 ºC both sustained over a 24 hour period), neutropenic infection (grade ≥ 3 neutropenia with grade ≥ 3 infection), anemia ≥ grade 4, grade \> 4 thrombocytopenia or grade ≥ 3 thrombocytopenia and grade ≥ 3 hemorrhage, or grade 3 or 4 nonh
Interventions
- DRUG TRC105 and Pazopanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2013-12-10 |
| Est. Completion | 2019-03-11 |
| Phase | Phase 1 |
What the finished NCT01975519 record still lists
NCT01975519 is an interventional study that assigns participants to a tested intervention. The registered 111 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 (85% higher).
The record links to 0 conditions, and to 1 intervention - of which TRC105 and Pazopanib is the first listed.
NCT01975519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01975519 about?
NCT01975519 is a clinical study titled "A Phase 1B Dose-escalation and Phase 2a Study of Carotuximab (TRC105) in Combination With Pazopanib in Patients With Advanced Soft Tissue Sarcoma". 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 pazopanib in patients with advanced soft tissue sarcoma. Up to 30 patients will be treated. The purpose of the phase 2 portion is to estimate th...
What is the current status of trial NCT01975519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2013-12-10. Estimated completion is 2019-03-11.
What interventions are being tested in trial NCT01975519?
The interventions under investigation include: TRC105 and Pazopanib (DRUG).
Who is sponsoring clinical trial NCT01975519?
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 NCT01975519's enrollment target sits among peer trials
111 512th of 2000 higher than 1,487 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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