Ignite Creation Date:
2024-05-06 @ 2:36 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02082977
Status:
TERMINATED
Last Update Posted:
2020-02-25
First Post:
2014-01-16
Brief Title:
A Study to Investigate the Safety Pharmacokinetics Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With RelapsedRefractory Diffuse Large B Cell Lymphoma Transformed Follicular Lymphoma Other Non-Hodgkins Lymphomas Solid Tumors and Multiple Myeloma
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase I Open-label Dose Escalation Study to Investigate the Safety Pharmacokinetics Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With RelapsedRefractory Diffuse Large B Cell Lymphoma Transformed Follicular Lymphoma Other Non-Hodgkins Lymphomas Solid Tumors and Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The maximal dose and schedule attained with GSK2816126 has shown insufficient evidence of clinical activity and does not justify further clinical investigation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multicenter 2-part study to determine the recommended Phase 2 dose RP2D for GSK2816126 given twice weekly by intravenous IV infusion Part 1 will be conducted in adult subjects with relapsedrefractory diffuse large B cell lymphoma DLBCL transformed follicular lymphoma tFL other Non-Hodgkins lymphomas NHL solid tumors including castrate resistant prostate cancer and multiple myeloma MM to determine the safety and tolerability of GSK2816126 Expansion cohorts Part 2 are planned to further explore clinical activity of GSK2816126 at the RP2D in subjects with Enhancer of Zeste 2 EZH2 wild type and EZH2 mutant positive germinal center B-cell like diffuse large B cell lymphoma GCB-DLBCL tFL and MM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2013-001585-42 | EUDRACT_NUMBER | None | None |