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GSK2141795

Phase 1

Cancer | Small molecule | Oncology |GSK plc|Last Updated: Nov 13, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

GSK2141795 · 2 trials · 2 indications

Phase 1 2
NCT01266954An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian CancerSolid Tumours
COMPLETED36 Analytics
NCT00920257A Phase I, Open-Label, First-Time-In-Human Study of the Oral AKT Inhibitor GSK2141795Cancer
COMPLETED77 Analytics
PHASE1COMPLETED
An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian Cancer
Solid TumoursUnlock trial analytics
PHASE1COMPLETED
A Phase I, Open-Label, First-Time-In-Human Study of the Oral AKT Inhibitor GSK2141795
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The amount of GSK2141795 in the blood (ng/ml) from baseline
6 months
To determine the recommended Phase II dose and schedule of GSK214179 using the following information: safety and tolerability, pharmacokinetic (single and repeat dose administration) and pharmacodynamic data
Continune until disease progression or consent withdrawn

Secondary Endpoints

The net unidirectional uptake of FDG (Ki) from baseline
6 months
The change in size of tumor from baseline (RECIST Criteria)
6 months
• To explore the clinical efficacy of GSK2141795 in subjects with solid tumor malignancies or lymphomas
Continune until disease progression or consent withdrawn
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Stage 1EXPERIMENTALThree to six patients on a medium dose of GSK2141795 for four weeks
Stage 2EXPERIMENTALNine to eighteen subjects on a low, medium or high dose of GSK2141795 for four weeks
GSK2141795EXPERIMENTALOral GSK214179 given daily to patients with cancer. Groups of approximately three patients will receive GSK2141795 at increasing doses until a maximum tolerated dose is identified.

Interventions

NameTypeDescription
GSK2141795DRUGGSK2141795 is an oral, low nanomolar pan-AKT kinase inhibitor that demonstrates activity in hematologic and solid tumor cell lines. It also delays tumor growth in a dose dependent manner in solid tumor xenograft mouse models
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Eligibility Criteria

Age Range18 Years to 85 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Capable of giving written informed consent 2. Females of non-childbearing potential, 18 years or older with ovarian cancer 3. Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent ovarian cancer 4. Histologically or cytologically confirme...

Countries:United KingdomUnited StatesCanada
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Frequently asked questions about GSK2141795

What is GSK2141795 used for?

GSK2141795 is an investigational small molecule being studied for the treatment of cancer and solid tumours. It is an oral AKT inhibitor that has been evaluated in Phase 1 clinical trials. The drug is not approved and remains in clinical development.

What does GSK2141795 target?

GSK2141795 targets AKT, a protein involved in cell survival and growth pathways. By inhibiting AKT, the drug aims to interfere with cancer cell proliferation. This mechanism was studied in early-phase trials for cancer and solid tumours.

Who makes GSK2141795?

GSK2141795 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company has conducted clinical trials to evaluate the drug's safety and efficacy in oncology.

What phase is GSK2141795 in?

GSK2141795 is in Phase 1 of clinical development. It has completed Phase 1 trials, but it is not approved by regulatory authorities. The drug is still investigational and has not progressed to later-stage trials.

What clinical trials is GSK2141795 in?

GSK2141795 has been studied in two completed Phase 1 trials. NCT00920257 enrolled 77 participants with cancer in the United States and Canada. NCT01266954 enrolled 36 female participants with solid tumours in the United Kingdom, focusing on ovarian cancer.

Is GSK2141795 the same as an AKT inhibitor?

Yes, GSK2141795 is an AKT inhibitor. It is an oral small molecule designed to block AKT activity. The drug has been investigated in early-phase clinical trials for cancer and solid tumours, though it is not yet approved.