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NCT02630251 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of GSK2820151 in Subjects With Advanced or Recurrent Solid Tumors
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02630251 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 5 participants.
The verdict
NCT02630251, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The study drug, GSK2820151, is a Bromodomain (BRD) and Extra-Terminal (BET) inhibitor arising from a distinct structural class. GSK2820151 potently inhibits tumor growth in vitro and in vivo in animal models. This first time in human (FTIH), open-label, dose escalation study is to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK2820151 in subjects with advanced or recurrent solid tumors. The objective is to determine the safety, tolerability and maximum tolerated dose (MTD) of GSK2820151 in subjects 18 years or older with advanced or recurrent solid tumors. Eligible subjects with advanced or recurrent solid tumors will be enrolled in the dosing cohorts until MTD is established. All subjects will receive study drug. Subjects may continue treatment in the study until disease progression, unacceptable toxicity, or withdrawal of consent. The duration of study will depend on recruitment rates and the timing of subjects' duration on study (withdrawal rates due to toxicity or progression). It is anticipated that approximately 30 to 50 subjects will be enrolled.
Interventions
- DRUG GSK2820151
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2016-04-25 |
| Est. Completion | 2018-12-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02630251
The ClinicalTrials.gov registry entry for NCT02630251 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GSK2820151 is the first listed.
NCT02630251 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02630251 about?
NCT02630251 is a clinical study titled "Dose Escalation Study of GSK2820151 in Subjects With Advanced or Recurrent Solid Tumors". The study drug, GSK2820151, is a Bromodomain (BRD) and Extra-Terminal (BET) inhibitor arising from a distinct structural class. GSK2820151 potently inhibits tumor growth in vitro and in vivo in animal models. This first time in human (FTIH), open-label, dose escalation study is to assess the safety,...
What is the current status of trial NCT02630251?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2016-04-25. Estimated completion is 2018-12-13.
What interventions are being tested in trial NCT02630251?
The interventions under investigation include: GSK2820151 (DRUG).
Who is sponsoring clinical trial NCT02630251?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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