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NCT03666988 · ClinicalTrials.gov registry record · Phase 1
First Time in Humans (FTIH) Study of GSK3368715 in Participants With Solid Tumors and Diffuse Large B-cell Lymphoma (DLBCL)
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT03666988 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 31 participants.
The verdict
NCT03666988, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study 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 relapsed/refractory 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 relapsed/refractory 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 relapsed/refractory solid tumors including pancreatic, bladder, and non-small cell lung cancer (NSCLC)(Expansion Cohort 2B). The study includes a screening period, an intervention period and follow up.
Interventions
- DRUG GSK3368715
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-10-22 |
| Est. Completion | 2021-03-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03666988
The ClinicalTrials.gov registry entry for NCT03666988 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 31 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 GSK3368715 is the first listed.
NCT03666988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03666988 about?
NCT03666988 is a clinical study titled "First Time in Humans (FTIH) Study of GSK3368715 in Participants With Solid Tumors and Diffuse Large B-cell Lymphoma (DLBCL)". 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 hemato...
What is the current status of trial NCT03666988?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2018-10-22. Estimated completion is 2021-03-04.
What interventions are being tested in trial NCT03666988?
The interventions under investigation include: GSK3368715 (DRUG).
Who is sponsoring clinical trial NCT03666988?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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