Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03666988
Status:
TERMINATED
Last Update Posted:
2022-05-20
First Post:
2018-09-10
Brief Title:
First Time in Humans FTIH Study of GSK3368715 in Participants With Solid Tumors and Diffuse Large B-cell Lymphoma DLBCL
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 GSK3368715 in Participants With Solid Tumors and DLBCL
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Overall benefit-risk profile did not support continuation of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Arginine methylation mediated by protein arginine methyl-transferases PRMTs is an important post-translational modification of proteins involved in a diverse range of cellular processes Misregulation and overexpression of PRMT1 a type I PRMT has been associated with a number of solid and hematopoietic cancers GSK3368715 leads to inhibition of tumor cell growth across tumor types with cytotoxic response observed in lymphoma acute myeloid leukemia AML and a subset of solid tumor cell lines This study will assess the safety pharmacokinetics PK pharmacodynamics PD food effect and preliminary clinical activity of GSK33368715 in participants with relapsedrefractory DLBCL and selected solid tumors with frequent methyl-thioadenosine phosphorylase MTAP-deficiency The study will consist of two parts In Part 1 Dose Escalation escalating doses of GSK3368715 will be evaluated and recommended phase 2 dose RP2D will be established in participants with selected solid relapsedrefractory tumors Once a RP2D is identified a food effect sub-study will be initiated to determine the effect of a high-fat high calorie meal on the bioavailability of GSK3368715 In Part 2 Dose Expansion this RP2D will be further investigated in two expansion cohorts participants with DLBCL Expansion Cohort 2A and relapsedrefractory solid tumors including pancreatic bladder and non-small cell lung cancer NSCLCExpansion Cohort 2B The study includes a screening period an intervention period and follow up
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 |
|---|---|---|---|
| 2018-001629-20 | EUDRACT_NUMBER | None | None |