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NCT04439175

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

Active, enrolled Phase 2 Results posted Last updated 18 November 2025
What this trial tests

Phase 2 trial testing Taselisib in Advanced Lymphoma in 70 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
25 February 2016
Primary endpoint
10 November 2020
19 March 2026

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment70
Start date25 February 2016
Primary completion10 November 2020
Estimated completion19 March 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Advanced Lymphoma or Advanced Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (ORR) Primary · 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

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.

GroupValue95% CI
Treatment (Taselisib)0NA – NA
6-Month Progression-free Survival (PFS) Rate Secondary · 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.

GroupValue95% CI
Treatment (Taselisib)19.912.0 – 29.3
Progression-free Survival (PFS) Secondary · 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.

GroupValue95% CI
Treatment (Taselisib)3.11.8 – 3.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Taselisib)
Serious: 23/66 (35%)
Deaths: 66/70

Serious adverse events (24 terms)

ReactionSystemTreatment (Taselisib)
DiarrheaGastrointestinal disorders
Lung infectionInfections and infestations
HyperglycemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
NauseaGastrointestinal disorders
DehydrationMetabolism and nutrition disorders
Thromboembolic eventVascular disorders
FatigueGeneral disorders
Sudden death NOSGeneral disorders
Abdominal painGastrointestinal disorders
ColitisGastrointestinal disorders
DysphagiaGastrointestinal disorders
Mucositis oralGastrointestinal disorders
VomitingGastrointestinal disorders
Urinary tract infectionInfections and infestations
Aspartate aminotransferase increasedInvestigations
Blood bilirubin increasedInvestigations
Weight lossInvestigations
AnorexiaMetabolism and nutrition disorders
HypokalemiaMetabolism and nutrition disorders
Neoplasms benign, malignant and unspecified (incl cysts andNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Adult respiratory distress syndromeRespiratory, thoracic and mediastinal disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
HypertensionVascular disorders
Other adverse events (26 terms — click to expand)

ReactionSystemTreatment (Taselisib)
FatigueGeneral disorders
DiarrheaGastrointestinal disorders
NauseaGastrointestinal disorders
HyperglycemiaMetabolism and nutrition disorders
Alanine aminotransferase increasedInvestigations
AnemiaBlood and lymphatic system disorders
Mucositis oralGastrointestinal disorders
Aspartate aminotransferase increasedInvestigations
White blood cell decreasedInvestigations
AnorexiaMetabolism and nutrition disorders
Abdominal painGastrointestinal disorders
Dry mouthGastrointestinal disorders
VomitingGastrointestinal disorders
Alkaline phosphatase increasedInvestigations
Rash maculo-papularSkin and subcutaneous tissue disorders
Neutrophil count decreasedInvestigations
HypoalbuminemiaMetabolism and nutrition disorders
MyalgiaMusculoskeletal and connective tissue disorders
ConstipationGastrointestinal disorders
BruisingInjury, poisoning and procedural complications
Lymphocyte count decreasedInvestigations
Platelet count decreasedInvestigations
HypokalemiaMetabolism and nutrition disorders
Peripheral sensory neuropathyNervous system disorders
DyspneaRespiratory, thoracic and mediastinal disorders
HypertensionVascular disorders

Most-reported serious reactions: Diarrhea, Lung infection, Hyperglycemia, Hyponatremia, Nausea, Dehydration, Thromboembolic event, Fatigue.

Data from ClinicalTrials.gov NCT04439175 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Signaling Pathways in Cancer: Therapeutic Targets, Combinatorial Treatments, and New Developments.
    Yip HYK, Papa A. · · 2021 · cited 167× · PMID 33809714 · DOI 10.3390/cells10030659
  2. Immunometabolism in cancer: basic mechanisms and new targeting strategy.
    Su R, Shao Y, Huang M, Liu D, et al · · 2024 · cited 28× · PMID 38755125 · DOI 10.1038/s41420-024-02006-2
  3. Advancements in precision nanomedicine design targeting the anoikis-platelet interface of circulating tumor cells.
    Tang M, Zhang Z, Wang P, Zhao F, et al · · 2024 · cited 12× · PMID 39220884 · DOI 10.1016/j.apsb.2024.04.034
  4. PIK3CAMutations in Breast Cancer Subtypes Other Than HR-Positive/HER2-Negative.
    Ascione L, Zagami P, Nicolò E, Crimini E, et al · · 2022 · cited 9× · PMID 36579519 · DOI 10.3390/jpm12111793
  5. Mutational analysis and protein profiling predict drug sensitivity in multiple myeloma cell lines.
    Giliberto M, Santana LM, Holien T, Misund K, et al · · 2022 · cited 5× · PMID 36523963 · DOI 10.3389/fonc.2022.1040730
  6. Tissue-agnostic biomarkers in solid tumors: current approvals and emerging candidates.
    Kim J, Kim HS, Nam M, Chae YK. · · 2025 · cited 3× · PMID 40576713 · DOI 10.1007/s10555-025-10274-2

Verify or expand the search:

Other trials of Taselisib

Trials testing the same drug.

Other recruiting trials for Advanced Lymphoma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04439175.

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