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GSK923295

Phase 1

Cancer | Small molecule | Oncology |GSK plc|Last Updated: Jul 12, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

GSK923295 · 1 trial · 1 indication

Phase 1 1
NCT00504790Phase I Study to Assess the Safety, Pharmacokinetics, & Pharmacodynamics of GSK923295 in Subjects w/ Refractory CancerCancer
COMPLETED39 Analytics
PHASE1COMPLETED
Phase I Study to Assess the Safety, Pharmacokinetics, & Pharmacodynamics of GSK923295 in Subjects w/ Refractory Cancer
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: - physical exam
at screen & Day(D) 1 of each cycle and follow-up(F/U)
- vital signs and lab tests
at screen & D1, 8, 15, & 22 for each cycle & F/U
- ECGs
at screen and D1, 8 & 15 for each cycle & F/U
continuous monitoring of adverse events
each visit

Secondary Endpoints

Plasma samples of GSK923295 taken at:
- Day 1 & 15 (Cycle 1) for Stage 1
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GSK923295EXPERIMENTALanti-mitotic compound under study

Interventions

NameTypeDescription
GSK923295DRUGanti-mitotic compound
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Signed, written informed consent provided. * a) Stage 1 Subjects: Histologically or cytologically confirmed diagnosis of solid tumor malignancy that is not responsive to accepted standard therapies, or for which there is no standard therapy. b) Stage 2 Subjects: Histologica...

Countries:United States
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Frequently asked questions about GSK923295

What is GSK923295 used for?

GSK923295 is an investigational small molecule being developed for the treatment of cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and effectiveness in patients.

Who makes GSK923295?

GSK923295 is being developed by GSK plc, a global pharmaceutical company. GSK plc is publicly traded on the London Stock Exchange under the ticker symbol GSK.

What phase is GSK923295 in?

GSK923295 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, pharmacokinetics, and pharmacodynamics in patients with cancer.

What clinical trials is GSK923295 in?

GSK923295 has been studied in one completed Phase 1 clinical trial with the identifier NCT00504790. This trial assessed the safety, pharmacokinetics, and pharmacodynamics of GSK923295 in subjects with refractory cancer. The trial enrolled 39 participants in the United States.

Is GSK923295 FDA approved?

GSK923295 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial (NCT00504790) evaluated its safety and other characteristics, but it has not yet received regulatory approval for any use.