Trial Outcomes & Findings for Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N) (NCT NCT04439149)

Last Updated: 2025-11-21

Results Overview

ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Tumor assessments occurred 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

Results posted on

2025-11-21

Participant Flow

Subprotocol N was activated on February 25, 2016. Twenty-four patients were enrolled on EAY131-N between May 5, 2016, and December 5, 2016. All patients were enrolled on the basis of the results from the NCI-MATCH assay.

Patients whose tumors harboring PTEN mutation/deletion without loss of PTEN protein expression were assigned to sub-protocol N. The mutation status was determined by MATCH central Oncomine assay for all patients in this arm.

Participant milestones

Participant milestones
Measure	Treatment (GSK2636771) Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
Overall Study STARTED	24
Overall Study Started Protocol Therapy	23
Overall Study Eligible and Treated	22
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (GSK2636771) Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
Overall Study Ineligible	1
Overall Study Never start protocol therapy	1
Overall Study Adverse Event	4
Overall Study Disease Progression	14
Overall Study Complicating disease	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (GSK2636771) n=22 Participants Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
Age, Continuous	64 years n=68 Participants
Sex: Female, Male Female	14 Participants n=68 Participants
Sex: Female, Male Male	8 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants
Race (NIH/OMB) Asian	0 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants
Race (NIH/OMB) Black or African American	1 Participants n=68 Participants
Race (NIH/OMB) White	20 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=68 Participants

PRIMARY outcome

Timeframe: Tumor assessments occurred 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

Population: Eligible and treated

Outcome measures

Outcome measures
Measure	Treatment (GSK2636771) n=22 Participants Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
Objective Response Rate (ORR)	0 percentage of participants

SECONDARY outcome

Timeframe: 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, from which 6-month PFS rate is determined

Population: Eligible and treated

Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.

Outcome measures

Outcome measures
Measure	Treatment (GSK2636771) n=22 Participants Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
6-month Progression-free Survival (PFS) Rate	4.8 percentage of participants Interval 0.6 to 16.6

SECONDARY outcome

Timeframe: 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

Population: Eligible and treated

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.

Outcome measures

Outcome measures
Measure	Treatment (GSK2636771) n=22 Participants Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
Progression Free Survival (PFS)	1.8 months Interval 1.7 to 3.6

Adverse Events

Treatment (GSK2636771)

Serious events: 8 serious events

Other events: 17 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (GSK2636771) n=23 participants at risk Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
Blood and lymphatic system disorders Anemia	8.7% 2/23 • Number of events 8 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
General disorders Fatigue	17.4% 4/23 • Number of events 8 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Skin and subcutaneous tissue disorders Urticaria	4.3% 1/23 • Number of events 8 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Gastrointestinal disorders Colonic hemorrhage	4.3% 1/23 • Number of events 8 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Gastrointestinal disorders Nausea	4.3% 1/23 • Number of events 8 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Investigations INR increased	4.3% 1/23 • Number of events 8 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Renal and urinary disorders Acute kidney injury	4.3% 1/23 • Number of events 8 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.

Other adverse events

Other adverse events
Measure	Treatment (GSK2636771) n=23 participants at risk Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
Blood and lymphatic system disorders Anemia	39.1% 9/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
General disorders Fatigue	39.1% 9/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Skin and subcutaneous tissue disorders Pruritus	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Gastrointestinal disorders Abdominal pain	21.7% 5/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Gastrointestinal disorders Bloating	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Gastrointestinal disorders Constipation	17.4% 4/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Gastrointestinal disorders Diarrhea	34.8% 8/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Gastrointestinal disorders Dyspepsia	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Gastrointestinal disorders Nausea	26.1% 6/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Gastrointestinal disorders Vomiting	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Investigations Alkaline phosphatase increased	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Investigations Aspartate aminotransferase increased	13.0% 3/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Investigations Creatinine increased	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Investigations Weight loss	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Metabolism and nutrition disorders Anorexia	13.0% 3/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Metabolism and nutrition disorders Hypocalcemia	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Metabolism and nutrition disorders Hypokalemia	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Metabolism and nutrition disorders Hypomagnesemia	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Nervous system disorders Dizziness	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Nervous system disorders Dysgeusia	13.0% 3/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Nervous system disorders Headache	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.
Vascular disorders Hypertension	8.7% 2/23 • Number of events 17 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Twenty-three patients were included in the toxicity analysis.

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60