Trial Outcomes & Findings for Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y) (NCT NCT04439123)

Last Updated: 2025-11-18

Results Overview

Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response 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. The 90% two-sided binomial exact confidence interval was calculated for ORR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

35 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

2025-11-18

Participant Flow

Subprotocol Y was activated on May 31, 2016. A total of 43 patients were assigned to this arm after screening, 42 from screening cohort and 1 from outside assay. Of the 43 patients, 35 patients were enrolled to arm Y between July 13, 2016 and August 10, 2017.

To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol Y, patients had to have an AKT mutation.

Participant milestones

Participant milestones
Measure	Treatment (Capivasertib) Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capivasertib: Given PO
Overall Study STARTED	35
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Capivasertib) Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capivasertib: Given PO
Overall Study Adverse Event	11
Overall Study Death	1
Overall Study Disease progression	19
Overall Study Withdrawal by Subject	2
Overall Study Still on treatment	2

Baseline Characteristics

Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Capivasertib) n=35 Participants Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capivasertib: Given PO
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=202 Participants
Age, Continuous	61 years n=202 Participants
Sex: Female, Male Female	30 Participants n=202 Participants
Sex: Female, Male Male	5 Participants n=202 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=202 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=202 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=202 Participants
Race (NIH/OMB) Asian	2 Participants n=202 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants
Race (NIH/OMB) Black or African American	5 Participants n=202 Participants
Race (NIH/OMB) White	27 Participants n=202 Participants
Race (NIH/OMB) More than one race	0 Participants n=202 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=202 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: Patients who were eligible and received protocol treatment

Outcome measures

Outcome measures
Measure	Treatment (Capivasertib) n=35 Participants Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capivasertib: Given PO
Overall Response Rate (ORR)	28.6 percentage of participants Interval 15.0 to 46.0

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: Patients who were eligible and received protocol treatment

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. 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 (Capivasertib) n=35 Participants Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capivasertib: Given PO
6-month Progression-free Survival (PFS) Rate	50 percentage of participants Interval 35.0 to 71.0

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: Patients who were eligible and received protocol treatment

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.

Outcome measures

Outcome measures
Measure	Treatment (Capivasertib) n=35 Participants Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capivasertib: Given PO
Progression Free Survival (PFS)	5.5 months Interval 4.6 to 11.3

Adverse Events

Treatment (Capivasertib)

Serious events: 20 serious events

Other events: 29 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Capivasertib) n=35 participants at risk Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capivasertib: Given PO
Blood and lymphatic system disorders Anemia	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Blood and lymphatic system disorders Febrile neutropenia	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.4% 4/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Diarrhea	8.6% 3/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Nausea	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Vomiting	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Alkaline phosphatase increased	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Aspartate aminotransferase increased	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Blood bilirubin increased	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Lymphocyte count decreased	8.6% 3/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Neutrophil count decreased	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hyperglycemia	25.7% 9/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypokalemia	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hyponatremia	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypophosphatemia	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Renal and urinary disorders Acute kidney injury	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Renal and urinary disorders Proteinuria	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Vascular disorders Hypertension	2.9% 1/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.

Other adverse events

Other adverse events
Measure	Treatment (Capivasertib) n=35 participants at risk Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capivasertib: Given PO
Skin and subcutaneous tissue disorders Rash maculo-papular	20.0% 7/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Nervous system disorders Headache	8.6% 3/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Blood and lymphatic system disorders Anemia	11.4% 4/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
General disorders Chills	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
General disorders Edema limbs	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
General disorders Fatigue	42.9% 15/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Skin and subcutaneous tissue disorders Dry skin	8.6% 3/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Skin and subcutaneous tissue disorders Pruritus	8.6% 3/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Skin and subcutaneous tissue disorders Rash acneiform	8.6% 3/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Abdominal pain	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Constipation	11.4% 4/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Diarrhea	54.3% 19/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Dry mouth	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Mucositis oral	11.4% 4/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Nausea	37.1% 13/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Vomiting	17.1% 6/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Infections and infestations Urinary tract infection	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Alanine aminotransferase increased	11.4% 4/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Alkaline phosphatase increased	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Aspartate aminotransferase increased	17.1% 6/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Creatinine increased	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Lymphocyte count decreased	17.1% 6/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Neutrophil count decreased	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Platelet count decreased	11.4% 4/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations Weight loss	11.4% 4/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Investigations White blood cell decreased	17.1% 6/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Anorexia	20.0% 7/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hyperglycemia	25.7% 9/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypomagnesemia	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Nervous system disorders Dizziness	8.6% 3/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Renal and urinary disorders Proteinuria	31.4% 11/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.
Vascular disorders Hypertension	5.7% 2/35 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 35 cases that received protocol treatment were monitored for adverse events.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60