Ignite Creation Date:
2024-05-06 @ 12:28 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01587703
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2012-04-03
Brief Title:
A Study to Investigate the Safety Pharmacokinetics Pharmacodynamics and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma NMC and Other Cancers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Open-Label Dose Escalation Study to Investigate the Safety Pharmacokinetics Pharmacodynamics and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma NMC and Other Cancers
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-004982-25 | EUDRACT_NUMBER | None | None |