Trial Outcomes & Findings for Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I) (NCT NCT04439175)

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

70 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 I was activated on February 25, 2016. 97 patients were assigned to Subprotocol I after screening, all from the screening cohort. Of the 97 patients, 70 patients enrolled in the study between March 2016 and April 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 subprotocol W, patients had to have tumors with an activating PIK3CA mutation.

Participant milestones

Participant milestones
Measure	Treatment (Taselisib) Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
Overall Study STARTED	70
Overall Study Started Protocol Therapy	66
Overall Study Eligible and Started Protocol Therapy	61
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Taselisib) Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
Overall Study Never started treatment	4
Overall Study Ineligible	5
Overall Study Adverse Event	6
Overall Study Death	4
Overall Study Disease progression	44
Overall Study Withdrawal by Subject	4
Overall Study Alternative Therapy	1
Overall Study Other	2

Baseline Characteristics

Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Taselisib) n=61 Participants Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
Age, Continuous	57 years n=202 Participants
Sex: Female, Male Female	43 Participants n=202 Participants
Sex: Female, Male Male	18 Participants n=202 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=202 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=202 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=202 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=202 Participants
Race (NIH/OMB) Asian	3 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	49 Participants n=202 Participants
Race (NIH/OMB) More than one race	1 Participants n=202 Participants
Race (NIH/OMB) Unknown or Not Reported	3 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

Outcome measures

Outcome measures
Measure	Treatment (Taselisib) n=61 Participants Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
Overall Response Rate (ORR)	0 percentage of participants There were no complete or partial responses.

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 is determined

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. The 6-month PFS rate was estimated using the Kaplan-Meier method which can provide a point estimate for any specific time point. 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 (Taselisib) n=61 Participants Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
6-Month Progression-free Survival (PFS) Rate	19.9 percentage of participants Interval 12.0 to 29.3

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

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 (Taselisib) n=61 Participants Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
Progression-free Survival (PFS)	3.1 months Interval 1.8 to 3.7

Adverse Events

Treatment (Taselisib)

Serious events: 23 serious events

Other events: 51 other events

Deaths: 66 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Taselisib) n=66 participants at risk Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
General disorders Fatigue	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
General disorders Sudden death NOS	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Abdominal pain	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Colitis	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Diarrhea	10.6% 7/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Dysphagia	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Mucositis oral	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Nausea	3.0% 2/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Vomiting	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Infections and infestations Lung infection	4.5% 3/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Infections and infestations Urinary tract infection	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations Aspartate aminotransferase increased	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations Blood bilirubin increased	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations Weight loss	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Metabolism and nutrition disorders Anorexia	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Metabolism and nutrition disorders Dehydration	3.0% 2/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Metabolism and nutrition disorders Hyperglycemia	4.5% 3/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Metabolism and nutrition disorders Hypokalemia	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Metabolism and nutrition disorders Hyponatremia	4.5% 3/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Vascular disorders Hypertension	1.5% 1/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Vascular disorders Thromboembolic event	3.0% 2/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.

Other adverse events

Other adverse events
Measure	Treatment (Taselisib) n=66 participants at risk Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
Blood and lymphatic system disorders Anemia	12.1% 8/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
General disorders Fatigue	37.9% 25/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.6% 5/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Abdominal pain	9.1% 6/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Constipation	6.1% 4/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Diarrhea	36.4% 24/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Dry mouth	9.1% 6/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Mucositis oral	12.1% 8/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Nausea	28.8% 19/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Gastrointestinal disorders Vomiting	9.1% 6/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Injury, poisoning and procedural complications Bruising	6.1% 4/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations Alanine aminotransferase increased	13.6% 9/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations Alkaline phosphatase increased	9.1% 6/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations Aspartate aminotransferase increased	12.1% 8/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations Lymphocyte count decreased	6.1% 4/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations Neutrophil count decreased	7.6% 5/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations Platelet count decreased	6.1% 4/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Investigations White blood cell decreased	12.1% 8/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Metabolism and nutrition disorders Anorexia	12.1% 8/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Metabolism and nutrition disorders Hyperglycemia	27.3% 18/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	7.6% 5/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Metabolism and nutrition disorders Hypokalemia	6.1% 4/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Musculoskeletal and connective tissue disorders Myalgia	7.6% 5/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Nervous system disorders Peripheral sensory neuropathy	6.1% 4/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.1% 4/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.
Vascular disorders Hypertension	6.1% 4/66 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 70 patients enrolled to the trial were monitored for mortality, the 66 treated patients were monitored for adverse events.

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