Active, not recruitingNCT04439175Updated May 6, 2026Results posted

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

A Phase 2 interventional study of Taselisib in Advanced Lymphoma, Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by National Cancer Institute (NCI). Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 4 years 3 months after the study started (first participant enrolled Feb 2016, registered Jun 2020).

Phase: Phase 2
Study type: Interventional
Enrollment: 70
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This phase II MATCH treatment trial identifies the effects of GDC-0032 (taselisib) in patients whose cancer has a genetic change called PIK3CA mutation. Taselisib may stop the growth of cancer cells by blocking PIK3CA, a protein that may be needed for cell growth. Researchers hope to learn if taselisib will shrink this type of cancer or stop its growth.

Read the detailed description

PRIMARY OBJECTIVE:

I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.

II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.

IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.

OUTLINE:

Patients receive taselisib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.

Conditions studied

Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma

Browse trials for

In context

Hematologic Neoplasms

1,463 studies on the registry are indexed under Hematologic Neoplasms; 432 are open to participants now.

This study's enrollment of 70 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
Patients must have a PIK3CA mutation as determined via the MATCH Master Protocol
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 with known left ventricular dysfunction must have echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 4 weeks prior to registration to treatment and must not have left ventricular ejection fraction (LVEF) \< institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible
Patients must have a fasting glucose =\< 125 mg/dL
- NOTE: Please provide clear documentation that the glucose test was conducted at a fasting state
Patients with prior treatment with an mTOR inhibitor are acceptable. These include, but are not limited to: temsirolimus, everolimus, ridaforolimus, sirolimus, CC-223, MLN128 (INK128), DS-3078, CC-115, AZD-2014, AZD8055

Exclusion criteria

Exclusion Criteria:

Patients must not have known hypersensitivity to GDC-0032 (taselisib) or compounds of similar chemical or biologic composition
Patients must not have breast cancer
Patients with squamous cell carcinoma of the lung who have PIK3CA mutations who have access to AND are eligible for Lung-MAP (S1400) are not eligible
Patients must not have KRAS mutations, and/or PTEN mutation or loss, detected in the tumor sample as determined by the MATCH screening assessment. PTEN loss will be determined by immunohistochemistry
Patients must not have had prior therapy with a PI3K inhibitor or PI3K/mTOR inhibitor. These include, but are not limited to: BEZ235, XL-765 (SAR245409), GDC-0980, PF-04691502, PF-05212384 (PKI-587), SF-1126, GSK 2126458, P-7170, BGT-226, LY3023414, GDC-0084, DS-7423, BKM-120 (buparlisib), PX-866, XL-147, GDC-0941 (pictilisib), VS-5584, BAY-80-6946, ZSTK-474, WX 037, AZD8835, GSK2636771, GS-9820, BYL719, MLN1117 (INK1117), idelalisib, TGR1202, RP6530, duvelisib (IPI-145), CUDC-907. Prior GDC-0032 (taselisib) is not allowed
Patients must not have had prior therapy with an Akt inhibitor. These include, but are not limited to: MK-2206, GSK690693, AZD5363, triciribine, perifosine, GSK2141795, GSK2110183, SR13668, BAY1125976, GDC-0068 (ipatasertib), LY2780301, ARQ092
Patients must not have type 1 or 2 diabetes requiring anti-hyperglycemic medication (e.g. metformin, glipizide, insulin)
Patients must not have current dyspnea at rest or require any daily supplemental oxygen
Patients must not have history of inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or active bowel inflammation (e.g. diverticulitis)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 70 participants (actual)

Study arms

Experimental
Treatment (taselisib)
Patients receive taselisib 4 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Taselisib

Interventions

DrugTaselisib
Given PO
Also known as: GDC-0032, RO5537381

What researchers measure

Primary outcomes

Overall Response Rate (ORR)
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.
Time frame: 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

Secondary outcomes

6-Month Progression-free Survival (PFS) Rate
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.
Time frame: 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
Progression-free Survival (PFS)
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.
Time frame: 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

Results

Posted Dec 28, 2022

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.

Participant flow — Overall Study
Milestone	Treatment (Taselisib)
Started	70
Started protocol therapy	66
Eligible and started protocol therapy	61
Completed	0
Not completed	70
Withdrew: Never started treatment	4
Withdrew: Ineligible	5
Withdrew: Adverse event	6
Withdrew: Death	4
Withdrew: Disease progression	44
Withdrew: Withdrawal by subject	4
Withdrew: Alternative therapy	1
Withdrew: Other	2

Outcome measures

PrimaryOverall Response Rate (ORR)

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.

Time frame:: 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
Reported as:: Number · percentage of participants

Overall Response Rate (ORR)
percentage of participants	Treatment (Taselisib)
Overall Response Rate (ORR)	0 (NA to NA)

Secondary6-Month Progression-free Survival (PFS) Rate

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.

Time frame:: 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
Reported as:: Number · percentage of participants

6-Month Progression-free Survival (PFS) Rate
percentage of participants	Treatment (Taselisib)
6-Month Progression-free Survival (PFS) Rate	19.9 (12.0 to 29.3)

SecondaryProgression-free Survival (PFS)

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.

Time frame:: 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
Reported as:: Median · months

Progression-free Survival (PFS)
months	Treatment (Taselisib)
Progression-free Survival (PFS)	3.1 (1.8 to 3.7)

Adverse events

Collected over Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment (Taselisib)	66/70 (94.3%)	23/66 (34.8%)	51/66 (77.3%)

Most frequent serious events

Showing 10 of 24

Most frequent serious events
Event	Treatment (Taselisib)
DiarrheaGastrointestinal disorders	7/66
Lung infectionInfections and infestations	3/66
HyperglycemiaMetabolism and nutrition disorders	3/66
HyponatremiaMetabolism and nutrition disorders	3/66
NauseaGastrointestinal disorders	2/66
DehydrationMetabolism and nutrition disorders	2/66
Thromboembolic eventVascular disorders	2/66
FatigueGeneral disorders	1/66
Sudden death NOSGeneral disorders	1/66
Abdominal painGastrointestinal disorders	1/66

Most frequent other events

Showing 10 of 26

Most frequent other events
Event	Treatment (Taselisib)
FatigueGeneral disorders	25/66
DiarrheaGastrointestinal disorders	24/66
NauseaGastrointestinal disorders	19/66
HyperglycemiaMetabolism and nutrition disorders	18/66
Alanine aminotransferase increasedInvestigations	9/66
AnemiaBlood and lymphatic system disorders	8/66
Mucositis oralGastrointestinal disorders	8/66
Aspartate aminotransferase increasedInvestigations	8/66
White blood cell decreasedInvestigations	8/66
AnorexiaMetabolism and nutrition disorders	8/66

Baseline characteristics

Eligible and treated patients

Age, Continuous
Age, Continuous(years)	Treatment (Taselisib)
Median	57 (25 to 76)

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment (Taselisib)
Female	43
Male	18

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Treatment (Taselisib)
Hispanic or Latino	2
Not Hispanic or Latino	57
Unknown or Not Reported	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Treatment (Taselisib)
American Indian or Alaska Native	0
Asian	3
Native Hawaiian or Other Pacific Islander	0
Black or African American	5
White	49
More than one race	1
Unknown or Not Reported	3

Study locations

1 site

ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania 19103, United States

References and documents

Study documents

Study protocol · Jan 25, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04439175
Lead sponsor: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jun 19, 2020
Start date: Feb 25, 2016
Primary completion: Nov 10, 2020
Completion: Mar 31, 2027 (estimated)
Results posted: Dec 28, 2022
Last update: May 6, 2026

Study contacts

Ian E Krop

principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hematologic Neoplasms→

Other studies from this sponsor

National Cancer Institute (NCI)

Start the discussion