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PI3K-beta Inhibitor

PI3K-beta Inhibitor for Tumors

Phase 2
Waitlist Available
Led By Filip Janku
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a serum creatinine that =< 1.5 x upper limit of normal (ULN) or have a 24-hour creatinine clearance of >= 50 mL/min
There must be evidence of PTEN expression by immunohistochemistry (IHC) (any amount of staining will be considered positive for expression)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Awards & highlights

Study Summary

This trial is testing a drug to see if it can shrink or stop the growth of cancer in patients whose cancer has a specific genetic change.

Who is the study for?
This trial is for cancer patients with a specific genetic change called PTEN mutation or deletion. They must have some PTEN expression, normal hemoglobin levels, acceptable kidney function, and a stable heart rhythm on an ECG. Excluded are those allergic to GSK2636771, with certain other gene changes that affect cancer growth pathways, prior treatments targeting similar pathways, history of lung disease like pneumonitis, congenital platelet defects or current use of certain anti-platelet drugs.Check my eligibility
What is being tested?
The trial tests the drug GSK2636771 in cancers with PTEN mutations. This drug aims to block PI3K-beta protein which might be essential for the growth of these cancer cells. The goal is to see if this targeted treatment can shrink tumors or halt their progression.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the drug's components; issues related to blocked PI3K-beta pathway such as blood sugar imbalances; and possibly increased risk of infections due to immune system interference.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Select...
My cancer shows PTEN protein presence.
Select...
My recent ECG showed no significant heart issues.
Select...
My cancer has a PTEN gene mutation or deletion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Overall survival (OS)
Progression free survival (PFS)

Side effects data

From 2019 Phase 1 trial • 37 Patients • NCT02215096
55%
Diarrhoea
36%
Nausea
27%
Fatigue
27%
Anaemia
18%
Hypophosphataemia
18%
Hypocalcaemia
18%
Cough
18%
Blood creatinine increased
18%
Dizziness
18%
Decreased appetite
18%
Blood alkaline phosphatase increased
18%
Neutropenia
18%
Dysgeusia
18%
Haematuria
18%
Constipation
18%
Pain in extremity
18%
Hyperkalaemia
18%
Oropharyngeal pain
9%
Sinus bradycardia
9%
Insomnia
9%
Palpitations
9%
Hyperglycaemia
9%
Skin laceration
9%
Inguinal hernia
9%
Back pain
9%
Epistaxis
9%
Blood phosphorus increased
9%
Agitation
9%
Hypotension
9%
Face oedema
9%
Hydronephrosis
9%
Abdominal pain
9%
Abdominal tenderness
9%
Hypertension
9%
Hot flush
9%
Dyspepsia
9%
Urinary tract infection
9%
Proteinuria
9%
Hypernatraemia
9%
Malaise
9%
Fall
9%
Hypoalbuminaemia
9%
Chills
9%
Cellulitis
9%
Mouth ulceration
9%
Nasopharyngitis
9%
Rash
9%
Hypersensitivity
9%
Paraesthesia
9%
Myalgia intercostal
9%
Arthralgia
9%
Lymphocyte count decreased
9%
Dry skin
9%
Pelvic pain
9%
Arthritis
9%
Aspartate aminotransferase increased
9%
Confusional state
9%
Abdominal distension
9%
Hyponatraemia
9%
Pyrexia
9%
Alopecia
9%
Conjunctivitis
9%
Gout
9%
Peripheral swelling
9%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
GSK2636771 200mg/Enzalutamide 160mg Escalation
Enzalutamide Only (run-in Period)
GSK2636771 200mg/Enzalutamide 160mg Expansion
GSK2636771 300mg/Enzalutamide 160mg Escalation
GSK2636771 400mg/Enzalutamide 160mg Escalation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (GSK2636771)Experimental Treatment1 Intervention
Patients receive PI3K-beta inhibitor GSK2636771 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,118 Total Patients Enrolled
Filip JankuPrincipal InvestigatorECOG-ACRIN Cancer Research Group
7 Previous Clinical Trials
260 Total Patients Enrolled

Media Library

GSK2636771 (PI3K-beta Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439149 — Phase 2
Cancer Research Study Groups: Treatment (GSK2636771)
Cancer Clinical Trial 2023: GSK2636771 Highlights & Side Effects. Trial Name: NCT04439149 — Phase 2
GSK2636771 (PI3K-beta Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439149 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to join this experiment?

"This clinical trial has finished recruiting participants. Initial postings were made on February 25th 2016 and the last update was September 16th 2022. For those seeking alternative studies, there are currently 4670 trials focused on lymphoid cells actively enrolling patients and 4 different trials targeting PI3K-beta Inhibitor GSK2636771 that are also accepting recruits."

Answered by AI

What is the uppermost limit for participants in this experiment?

"At the present moment, this medical research is not recruiting patients. It was first listed on February 25th 2016 and last edited on September 16th 2022. Currently, there are 4670 clinical trials requiring lymphoid cell candidates as well as 4 studies investigating PI3K-beta Inhibitor GSK2636771 that require participants."

Answered by AI

What precedents have been set by prior clinical trials of PI3K-beta Inhibitor GSK2636771?

"Presently, there are 4 clinical trials featuring PI3K-beta Inhibitor GSK2636771 in progress, with none currently at Phase 3. While Philadelphia is one of the cities operating these studies for this inhibitor, 1460 other sites worldwide have similar ongoing research projects."

Answered by AI

What health risks have been associated with PI3K-beta Inhibitor GSK2636771?

"Though not yet proven effective, there is prior evidence demonstrating PI3K-beta Inhibitor GSK2636771's safety, manifesting in a rating of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N)
2016. "Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439149.
~2 spots leftby Nov 2024
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