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NCT03454035 · ClinicalTrials.gov registry record · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
A Phase 1 study of Pancreatic Cancer and Melanoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT03454035: Recruiting Phase 1 study of Pancreatic Cancer and Melanoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03454035 is a Phase 1 study of Pancreatic Cancer and Melanoma that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 45 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03454035, a Phase 1 study of Pancreatic Cancer and Melanoma, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.
Primary Outcome
MTD of ulixertinib in combination with palbociclib in patients with advanced solid tumors of ulixertinib in combination with palbociclib in patients with advanced solid tumors
Conditions Studied
Interventions
- DRUG Palbociclib
- DRUG Ulixertinib
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-01-30 |
| Est. Completion | 2026-11-24 |
| Phase | Phase 1 |
What NCT03454035 shows while recruiting
NCT03454035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which Palbociclib is the first listed.
NCT03454035 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03454035 about?
NCT03454035 is a clinical study titled "Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors". This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.
What is the current status of trial NCT03454035?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2018-01-30. Estimated completion is 2026-11-24.
What conditions does trial NCT03454035 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Melanoma, Tumor, Solid.
What interventions are being tested in trial NCT03454035?
The interventions under investigation include: Palbociclib (DRUG), Ulixertinib (DRUG).
Who is sponsoring clinical trial NCT03454035?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03454035 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03454035's enrollment target sits among peer trials
45 162nd of 278 higher than 115 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer 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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