Trial Title:
Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)
NCT ID:
NCT05490771
Condition:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Hematopoietic and Lymphatic System Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Conditions: Official terms:
Lymphoma
Neoplasms
Multiple Myeloma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo tumor biopsy
Arm group label:
Treatment (copanlisib)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (copanlisib)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Copanlisib Hydrochloride
Description:
Given IV
Arm group label:
Treatment (copanlisib)
Other name:
5-Pyrimidinecarboxamide, 2-Amino-N-(2,3-dihydro-7-methoxy-8-(3-(4-morpholinyl)propoxy)imidazo(1,2-C)quinazolin-5-yl)-, Hydrochloride (1:2)
Other name:
Aliqopa
Other name:
BAY 80-6946 Dihydrochloride
Other name:
BAY-80-6946 Dihydrochloride
Other name:
Copanlisib Dihydrochloride
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (copanlisib)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Summary:
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.
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 copanlisib intravenously (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
computed tomography (CT) or magnetic resonance imaging (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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ECOG-ACRIN Cancer Research Group
Address:
City:
Philadelphia
Zip:
19103
Country:
United States
Start date:
June 20, 2018
Completion date:
December 31, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490771
