Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01587703 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 196
- Enrollment target
NCT01587703: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01587703 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 196 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (227% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01587703, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 196 participants
- Enrollment target
Study Summary
This study is divided into two parts; Part 1 of the study is a dose escalation phase to select the recommended dose for Part 2 based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after oral administration of GSK525762 in the following subjects: NMC, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), neuroblastoma (NB), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), estrogen receptor positive (ER positive) breast cancer, and MYCN driven solid tumor subjects. Part 2 of the study will explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of the recommended dose from Part 1 in cohorts comprised of NMC, small cell lung cancer (SCLC), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), and estrogen receptor positive (ER positive) breast cancer subjects. Approximately 60 subjects will be enrolled in the Part 1 and approximately 150 subjects will be enrolled in Part 2. A sub-study will be opened in Part 1 to approximately 10-12 subjects in the United States to investigate the relative bioavailability of the besylate tablet compared to the amorphous free-base tablet at the maximum tolerated dose (MTD) or recommended phase 2 dosing (RP2D), the effect of high-fat high-calorie meal on the bioavailability of the besylate tablet at the MTD or RP2D and the dose proportionality of 2 doses of GSK525762 administered as besylate tablet.
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require
Interventions
- DRUG GSK525762
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2012-03-28 |
| Est. Completion | 2019-07-29 |
| Phase | Phase 1 |
What the finished NCT01587703 record still lists
NCT01587703 is an interventional study that assigns participants to a tested intervention. The registered 196 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 (227% higher).
The record links to 0 conditions, and to 1 intervention - of which GSK525762 is the first listed.
NCT01587703 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01587703 about?
NCT01587703 is a clinical study titled "A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers". This study is divided into two parts; Part 1 of the study is a dose escalation phase to select the recommended dose for Part 2 based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after oral administration of GSK525762 in the following subjects: NMC, small cell lung cancer (SC...
What is the current status of trial NCT01587703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 196 participants. The study started on 2012-03-28. Estimated completion is 2019-07-29.
What interventions are being tested in trial NCT01587703?
The interventions under investigation include: GSK525762 (DRUG).
Who is sponsoring clinical trial NCT01587703?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01587703's enrollment target sits among peer trials
196 279th of 2000 higher than 1,720 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02822768 · 196 participants · NA
Packing Versus no Packing for Cutaneous Abscess
- NCT04250259 · 196 participants · Phase 2
SAMe Trial for Patients With Alcoholic Cirrhosis
- NCT05142592 · 196 participants · Phase 1
Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
- NCT05317832 · 196 participants · Phase 2
Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI