Trial · NCT04439175
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
NCT04439175, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2022-12-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I). Trials, record NCT04439175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04439175
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
- NCT number
- NCT04439175
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Multiple Myeloma
- Interventions
- Taselisib
- First posted
- 2020-06-19
- Last updated
- 2026-11-06
- Results first posted
- 2022-12-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 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. |
| Secondary | 6-Month Progression-free Survival (PFS) Rate | 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. |
| Secondary | Progression-free Survival (PFS) | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | 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 | percentage of participants | NUMBER | |
| SECONDARY | 6-Month Progression-free Survival (PFS) Rate | 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 | percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | 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 | months | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Treatment (Taselisib) | 0 | 90% Confidence Interval NA to NA | percentage of participants | |
| 6-Month Progression-free Survival (PFS) Rate | Treatment (Taselisib) | 19.9 | 90% Confidence Interval 12.0 to 29.3 | percentage of participants | |
| Progression-free Survival (PFS) | Treatment (Taselisib) | 3.1 | 90% Confidence Interval 1.8 to 3.7 | months |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Taselisib) | 70 | |
| Overall Study | Started Protocol Therapy | Treatment (Taselisib) | 66 | |
| Overall Study | Eligible and Started Protocol Therapy | Treatment (Taselisib) | 61 | |
| Overall Study | COMPLETED | Treatment (Taselisib) | 0 | |
| Overall Study | NOT COMPLETED | Treatment (Taselisib) | 70 |
Source ClinicalTrials.gov
Adverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Taselisib) | 8 | 66 | |
| other | Fatigue | General disorders | Treatment (Taselisib) | 25 | 66 | |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Treatment (Taselisib) | 5 | 66 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Taselisib) | 6 | 66 | |
| other | Constipation | Gastrointestinal disorders | Treatment (Taselisib) | 4 | 66 | |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Taselisib) | 24 | 66 | |
| other | Dry mouth | Gastrointestinal disorders | Treatment (Taselisib) | 6 | 66 | |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Taselisib) | 8 | 66 | |
| other | Nausea | Gastrointestinal disorders | Treatment (Taselisib) | 19 | 66 | |
| other | Vomiting | Gastrointestinal disorders | Treatment (Taselisib) | 6 | 66 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Taselisib) | 66 | 70 |
| Total, other adverse events | Treatment (Taselisib) | 51 | 66 |
| Total, serious adverse events | Treatment (Taselisib) | 23 | 66 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U24CA196172 | ECOG-ACRIN Biospecimen Bank to Support NCTN | JEWELL, SCOTT D; HAMILTON, STANLEY R. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2015 to 2025 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04439175
GET https://conductscience.org/api/trials/v1/NCT04439175/events?page=2