New drug targets Hard-to-Treat cancers with PTEN loss
NCT ID NCT04439188
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests a drug called GSK2636771 in 35 patients whose cancers have lost a protein called PTEN. The drug blocks a growth signal that these cancers may rely on. Researchers hope to see if it can shrink tumors or stop them from growing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GSK2636771 (a PI3K-beta inhibitor)
- What this could lead to
- If it works, this could point toward a treatment for cancers with PTEN loss, offering a new option for patients with advanced or refractory tumors.
- What could go wrong
- This is a small, early-phase trial (35 patients) with no control group. The drug may not shrink tumors or stop growth, and side effects are possible. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
35 people
The number who actually took part.
- Started
-
Mar 2016
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol * 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) * Patients must have complete loss of cytoplasmic and nuclear PTEN staining on immunohistochemistry as determined by the MATCH PTEN immunohistochemistry (IHC) assay performed at MD Anderson. Patients can have any PTEN mutation or deletion status, but MUST have PTEN loss by IHC * Patients must have hemoglobin \>= 9 g/dL * 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 Exclusion Criteria: * Patients must not have known hypersensitivity to GSK2636771 or compounds of similar chemical or biologic composition * Patients must not have tumors harboring co-existing aberrations activating the PI3K/MTOR and MAPK pathways, such as PIK3CA, PIK3R1, BRAF, KRAS and AKT1, TSC1/2, mTOR, NF2, NRAS, HRAS, NF1 * Patients must not have received prior treatment with agents targeting the PI3K beta, AKT, or mTOR: * This includes (but is not limited to): * mTOR inhibitors: temsirolimus, everolimus, ridaforolimus, sirolimus, salirasib, CC-223, INK128, DS-3078, CC-115, AZD-2014 * Dual PI3K/mTOR inhibitors: BEZ235, XL-765, GDC 0980, PF-04691502, GSK 2126458, Quinacrine, PKI-587, P-P7170, LY3023414, GDC 0084, DS 7423, CBLC-137 * Pan-PI3K inhibitors: BKM-120 (buparlisib), PX-866, XL-147, GDC-0941 (pictilisib), BAY-806946, ZSTK-474, WX 037, SRX5000, SRX2523, AMG511, PQR308, BAY 94-9343 * PI3K inhibitors with beta isoform activity: prior GSK2636771 is not allowed, nor is GS-9820, PQR3XX, KAR4139 * The following previous treatments are allowed: * BYL719 (PI3Kalpha inhibitor) * GDC-0032 (PI3Kalpha inhibitor) * INK1117 (PI3Kalpha inhibitor) * Idelalisib (PI3Kdelta inhibitor) * IPI-125 (PI3K gamma delta inhibitor) * TGR1202 (PI3Kdelta inhibitor) * SRX2558 (PI3Kdelta inhibitor) * RP6530 (PI3K gamma delta inhibitor) * PWT143 (PI3Kdelta inhibitor) * IPI443 (PI3K gamma delta inhibitor) * GNE293 (PI3Kdelta inhibitor) * Patients with a history of interstitial lung disease or pneumonitis are excluded * Patients must not have any congenital platelet function defects and cannot be on any of the following anti-platelet drugs: clopidogrel, ticlopidine, prasugrel, that act at platelet purinergic receptors * Any need for starting anti-platelet therapy in a patient enrolled to this arm will have to be evaluated by the subprotocol chair
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, 19103, United States
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