Recent Updates
Recently added Catalysts

GSK2141795

Phase 2

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

GSK2141795 development status

Highest phase Phase 2 run by Dana-Farber Cancer Institute (NCT01958112)
Phase scored for GSKPhase 1
Registered trials 4 across 2 sponsors since Jun 2009

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment113

FDA Designations

No designations recorded

GSK2141795 clinical trials

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Continune until disease progression or consent withdrawn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Continune until disease progression or consent withdrawn
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Cancer 7 trials

Unlock Competitive Intelligence

Frequently asked questions about GSK2141795

What is GSK2141795 used for?

GSK2141795 is an investigational small molecule being developed by GSK plc for the treatment of cancer, including solid tumours. It is currently in Phase 1 clinical development and is not approved by the FDA. The drug has been studied in patients with various types of cancer to evaluate its safety and pharmacokinetics.

What does GSK2141795 target?

GSK2141795 is an oral AKT inhibitor. It works by targeting the AKT protein, which is part of the PI3K/AKT signaling pathway often involved in cancer cell growth and survival. By inhibiting AKT, the drug aims to block this pathway and potentially slow or stop tumour growth.

Who makes GSK2141795?

GSK2141795 is developed by GSK plc, a global pharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in treating cancer.

What phase is GSK2141795 in?

GSK2141795 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities such as the FDA. The Phase 1 trials are designed to assess the drug's safety, tolerability, and pharmacokinetics in patients with cancer.

What clinical trials is GSK2141795 in?

GSK2141795 has been studied in two completed Phase 1 clinical trials. The first, NCT00920257, was a first-time-in-human study in patients with cancer. The second, NCT01266954, investigated the drug's pharmacokinetics and pharmacodynamics in women with ovarian cancer using FDG PET imaging.

Is GSK2141795 the same as an AKT inhibitor?

Yes, GSK2141795 is an AKT inhibitor. It is a small molecule designed to inhibit the AKT protein, which plays a role in cancer cell survival and proliferation. The drug is being studied as a potential treatment for solid tumours and other cancers.