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PI3K-beta Inhibitor

PI3K-beta Inhibitor for PTEN Loss-Related Cancers

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 is < 1.5 x upper limit of normal (ULN) or have a 24-hour creatinine clearance of > 50 mL/min
Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
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 a certain type of cancer. The cancer cells in this trial have a complete loss of PTEN expression.

Who is the study for?
This trial is for patients with various cancers, including solid tumors and blood-related cancers like lymphoma and multiple myeloma, that have lost PTEN expression. Participants must have normal heart rhythms and adequate hemoglobin levels. They can't join if they've had certain treatments targeting similar pathways or have lung disease, congenital platelet defects, or are on specific anti-platelet drugs.Check my eligibility
What is being tested?
The study tests GSK2636771's effectiveness in shrinking or halting the growth of cancer cells lacking PTEN expression. This drug aims to block PI3K-beta protein which might be essential for the proliferation of these cancer cells.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system suppression since it targets cellular growth pathways. Patients should watch out for signs of infection, abnormal bleeding due to platelet dysfunction, and any new respiratory symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine levels, is within the normal range.
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My recent ECG showed no significant heart issues.
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My cancer lacks PTEN as shown by a specific test.

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%
Skin laceration
9%
Sinus bradycardia
9%
Insomnia
9%
Palpitations
9%
Hyperglycaemia
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
13,657 Previous Clinical Trials
40,933,632 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: NCT04439188 — Phase 2
Cancer Research Study Groups: Treatment (GSK2636771)
Cancer Clinical Trial 2023: GSK2636771 Highlights & Side Effects. Trial Name: NCT04439188 — Phase 2
GSK2636771 (PI3K-beta Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439188 — 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 remaining openings available to participants in this investigation?

"Based on the information hosted by clinicaltrials.gov, this particular medical investigation is no longer seeking patients as of September 14th 2022. It was initially posted over 6 years ago in February 2016. Despite that fact, there are still 4667 other trials which require participants at the present moment."

Answered by AI

Are there additional research projects encompassing GSK2636771's PI3K-beta Inhibitor capabilities?

"Currently, there are 4 studies in progress regarding PI3K-beta Inhibitor GSK2636771 with no trials currently reaching Phase 3. Of these ongoing investigations, some of them can be found in Philadelphia, Pennsylvania but a total of 1460 locations have active research on the inhibitor."

Answered by AI

What is the upper limit for enrolment in this clinical research program?

"This trial is no longer enrolling participants, as the last edit was done on September 14th 2022. If you are searching for other medical trials, please note that there are currently 4663 studies actively recruiting candidates with advance directives and 4 studies seeking participant to test PI3K-beta Inhibitor GSK2636771."

Answered by AI

Has the FDA sanctioned GSK2636771 as a PI3K-beta Inhibitor?

"Due to the absence of data indicating efficacy, our team at Power assigned GSK2636771 a safety rating of 2 on a 1-3 scale. Phase 2 trials do however provide evidence that this inhibitor may be safe for use in clinical settings."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Loss of Expression (MATCH-Subprotocol P)
2016. "Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Loss of Expression (MATCH-Subprotocol P)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439188.
~2 spots leftby Nov 2024
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