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NCT02034123 · ClinicalTrials.gov registry record · Phase 1
Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT02034123 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 29 participants.
The verdict
NCT02034123, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
GSK2879552 is a potent, selective, mechanism-based inactivator of Lysine Specific Demethylase 1 (LSD1)/ CoRepressor for Element-1-Silencing Transcription factor (CoREST) activity. This is a phase I, open-label, multi-center, non-randomized, 2-part first time in human (FTIH) study for GSK2879552. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for GSK2879552 based on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) profiles observed after oral administration of GSK2879552. Any dose level(s) may be expanded up to 12 subjects in order to collect additional data on PK and PD.The safety and PK/PD data will be reviewed prior to the dose decision, and the dose escalation will be guided by the Neuenschwander -continuous reassessment method (N-CRM). Built-in safety constraints are in place to prevent exposing subjects to undue risk of toxicity. Once RP2D is identified, an expansion cohort (Part 2) of up to 30 subjects will be enrolled to further evaluate the clinical activity and tolerability of GSK2879552 in subjects with relapsed/refractory SCLC.
Interventions
- DRUG GSK2879552
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2014-02-04 |
| Est. Completion | 2017-04-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02034123
The ClinicalTrials.gov registry entry for NCT02034123 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 29 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 GSK2879552 is the first listed.
NCT02034123 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02034123 about?
NCT02034123 is a clinical study titled "Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma". GSK2879552 is a potent, selective, mechanism-based inactivator of Lysine Specific Demethylase 1 (LSD1)/ CoRepressor for Element-1-Silencing Transcription factor (CoREST) activity. This is a phase I, open-label, multi-center, non-randomized, 2-part first time in human (FTIH) study for GSK2879552. Par...
What is the current status of trial NCT02034123?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2014-02-04. Estimated completion is 2017-04-18.
What interventions are being tested in trial NCT02034123?
The interventions under investigation include: GSK2879552 (DRUG).
Who is sponsoring clinical trial NCT02034123?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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