Clinical trial · Interventional
Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)
MATCH Treatment Subprotocol Z1F: Phase II Study of Copanlisib in Patients With Tumors With PIK3CA Mutations (PTEN Loss Allowed)
NCT05490771CI-TRIAL-00110381active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II MATCH treatment trial identifies the effects of copanlisib hydrochloride (copanlisib) in patients whose cancer has a genetic change called PIK3CA mutation. Copanlisib may stop the growth of cancer cells by blocking PIK3, a protein needed for cell growth. Researchers hope to learn if copanlisib will shrink this type of cancer or stop its growth.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lymphoma | Lymphoma | CURATED_BROADER | 0.78 |
| Advanced Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Refractory Lymphoma | Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy Procedure | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Copanlisib Hydrochloride | Drug | Copanlisib | ALIAS |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (copanlisib)
- description
- Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsies at screening and end of treatment and CT or MRI at baseline, every 2 cycles for the first 26 cycles, and then every 3 cycles thereafter until progressive disease or start of another MATCH treatment step.
- interventionNames
- Procedure: Biopsy Procedure
- Procedure: Computed Tomography
- Drug: Copanlisib Hydrochloride
- Procedure: Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- 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 30 months post registration
- description
- ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable (ie, eligible, treated and PIK3CA mutation status confirmed) patients. Objective response is defined consistent with 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. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol * Patients must have 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 should stop using herbal medications at least 7 days prior to the first dose of copanlisib. Herbal medications include, but are not limited to: St. John's Wort, Kava, ephedra, gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng * Patients with type I or II diabetes mellitus must have glycosylated hemoglobin A1c (HbA1c) =\< 8.5% within 28 days from registration * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9 /L * Platelets \>= 100x10\^9/L * Hemoglobin (Hb) \> 9 g/dl * Total serum bilirubin \< 2.0 mg/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN) (\< 5 x ULN in patients with liver metastases) * Serum creatinine \< 1.5 x ULN * Men and women of child-bearing potential must agree to use contraception while receiving study treatment and for 1 month after the last dose of copanlisib Exclusion Criteria: * Patients must not have known hypersensitivity to copanlisib or compounds of similar chemical or biologic composition * Patients must not have had prior therapy with copanlisib or other PI3K inhibitors, AKT inhibitors or mTOR inhibitors * Patients must not have activating KRAS mutations * Patients must not have HER2 positive (3+ by immunohistochemistry \[IHC\] or fluorescence in situ hybridization \[FISH\] ratio \>= 2) breast cancer * Patients must not have indolent non-Hodgkin lymphoma (NHL) (follicular lymphoma, small lymphocytic lymphoma \[SLL\]/chronic lymphocytic leukemia \[CLL\], lymphoplasmacytic lymphoma \[LPL\], marginal zone lymphoma) or DLBCL (diffuse large B cell lymphoma) * Patients must not be on strong inhibitors or inducers of CYP3A4 within two weeks prior to start of study treatment and for the duration of study treatment * Patients must not be on anti-arrhythmic therapy other than digoxin or beta-blockers * Patients with non-healing wound, ulcer, or bone fracture are not eligible * Patients with history of or current interstitial pneumonitis are not eligible * NOTE: For solid tumors, cytomegalovirus (CMV) polymerase chain reaction (PCR) can be obtained at the discretion of treating physician or local institutional guidelines
References
Publications (0)
Data not yet available
No reference posted for this study.