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Trial Title:
Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C)
NCT ID:
NCT06390839
Condition:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Conditions: Official terms:
Lymphoma
Neoplasms
Palbociclib
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 biopsy
Arm group label:
Treatment (palbociclib)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (palbociclib)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (palbociclib)
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:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (palbociclib)
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
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
Given PO
Arm group label:
Treatment (palbociclib)
Other name:
6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
Other name:
Ibrance
Other name:
PD 0332991
Other name:
PD 332991
Other name:
PD 991
Other name:
PD-0332991
Other name:
PD0332991
Summary:
This phase II MATCH treatment trial tests how well palbociclib (PD-0332991) works in
treating patients with cancer that has certain genetic changes. Palbociclib (PD-0332991)
is in a class of medications called kinase inhibitors. It is used in patients whose
cancer has a certain mutation (change) in the CDK4 or CDK6 gene. It works by blocking the
action of mutated CDK4 or CDK6 that signals cancer cells to multiply. This helps to stop
or slow the spread of cancer cells.
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 palbociclib orally (PO) once daily (QD) on days 1-21 of each cycle.
Cycles repeat every 28 days in the absence of disease progression or unacceptable
toxicity. Additionally, patients undergo computed tomography (CT) or magnetic resonance
imaging (MRI) and blood sample collection throughout the trial. Patients may also undergo
a biopsy on study.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol
EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol
- Patients must have CDK4 amplification or CDK6 amplification, or another aberration,
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 must not have breast cancer, mantle cell lymphoma, myeloma, or liposarcoma
- Patients must not have known hypersensitivity to palbociclib or compounds of similar
chemical or biologic composition
- Patients with known or symptoms of left ventricular dysfunction will be excluded
- Patients must not have received prior therapy with a CDK4 or CDK6 inhibitor
(including but not limited to palbociclib, abemaciclib, or ribociclib)
- Patients must not be using drugs or foods that are known potent CYP3A4 inhibitors or
inducers, or are CYP3A substrates with narrow therapeutic indices
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:
March 12, 2017
Completion date:
March 24, 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/NCT06390839
