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NCT04439149Active, not recruitingPhase 2

Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N)

MATCH Treatment Subprotocol N: Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients With Tumors With PTEN Mutation or Deletion, With PTEN Expression on IHC

Source: ClinicalTrials.gov · Last updated 27 May 2026

Brief summary (registry, in English)

This phase II MATCH treatment trial identifies the effects of GSK2636771 in patients whose cancer has a genetic change called PTEN mutation or deletion. GSK2636771 may block a protein called PI3K-beta, which may be needed for growth of cancer cells that express PTEN mutations. Researchers hope to learn if GSK2636771 will shrink this type of cancer or stop its growth.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
24 (actual)
First submitted
18 Jun 2020
Start date
5 May 2016
Primary completion date
10 Nov 2020
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT04439149

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 24
  • From 5 May 2016 to the primary completion date, 10 Nov 2020
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients must not have received prior treatment with agents targeting the PI3K beta, AKT, or mTOR pathways:
    • 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 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)

Other illness

  • Patients must not have known hypersensitivity to GSK2636771 or compounds of similar chemical or biologic composition.
  • Patients with a history of interstitial lung disease or pneumonitis are excluded

Lab values

  • 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

Other

  • 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

Who the study is looking for

  • 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 PTEN gene mutation/deletion
    • There must be evidence of PTEN expression by immunohistochemistry (IHC) (any amount of staining will be considered positive for expression)
    • Patients with complete loss of PTEN by IHC, regardless of PTEN mutations/deletion status, will be enrolled into MATCH subprotocol EAY131-P, not this subprotocol (EAY131-N)
  • Patients must have hemoglobin \>= 9 g/dL
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ECOG-ACRIN Cancer Research Group
Coordinator of this site? Confirm its status		PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.