Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390839
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-27
Brief Title:
Testing Palbociclib PD-0332991 as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification MATCH - Subprotocol Z1C
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MATCH Treatment Subprotocol Z1C Phase II Study of Palbociclib PD-0332991 in Patients With Tumors With CDK4 or CDK6 Amplification
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 agents in patients with advanced refractory cancerslymphomasmultiple 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 cancerslymphomasmultiple 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
I To evaluate the proportion of patients with objective response OR to targeted study agents in patients with advanced refractory cancerslymphomasmultiple 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 cancerslymphomasmultiple 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01137 | REGISTRY | None | None |
| EAY131-Z1C | OTHER | None | None |
| EAY131-Z1C | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |