Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05685602
Status:
SUSPENDED
Last Update Posted:
2024-07-03
First Post:
2023-01-13
Brief Title:
CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Clinical Trial of CA-4948 in Combination With Gemcitabine and Nab-Paclitaxel in Metastatic or Unresectable Pancreatic Ductal Carcinoma
Status:
SUSPENDED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other - pending amendment
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety side effects and best dose of emavusertib CA-4948 in combination with gemcitabine and nab-paclitaxel in treating patients with pancreatic ductal adenocarcinoma that has spread from where it first started primary site to other places in the body metastatic or cannot be removed by surgery unresectable CA-4948 is in a class of medications called kinase inhibitors It works by blocking the action of abnormal proteins called interleukin-1 receptor-associated kinase 4 IRAK4 and FMS-like tyrosine kinase 3 FLT3 that signal cells to multiply This may help keep cancer cells from growing The usual approach for patients with pancreatic ductal adenocarcinoma is treatment with chemotherapy drugs gemcitabine and nab-paclitaxel Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells Paclitaxel is in a class of medications called anti-microtubule agents It stops cancer cells from growing and dividing and may kill them Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel Giving CA-4948 in combination with gemcitabine and nab-paclitaxel may shrink or stabilize metastatic or unresectable pancreatic ductal adenocarcinoma
Detailed Description:
PRIMARY OBJECTIVE
I To assess dose limiting toxicities and determine the recommended phase 2 dose of emavusertib CA--4948 in combination with chemotherapy in patients with pancreatic ductal adenocarcinoma
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity II To evaluate the safety and tolerability of the combination of CA-4948 and chemotherapy
III To determine preliminary signals of efficacy as measured by objective response rate ORR CA-4948 response progression free survival PFS and overall survival OS
EXPLORATORY OBJECTIVES
I To evaluate pharmacodynamic effect of CA-4948 in combination with chemotherapy
II To evaluate pharmacokinetics of CA-4948 in combination with chemotherapy III To explore biomarkers and genomic alterations associated with treatment response
OUTLINE This is a dose-escalation study of CA-4948 in combination with fixed-dose gemcitabine and nab-paclitaxel followed by a dose-expansion study
Patients receive CA-4948 orally PO gemcitabine intravenously IV and nab-paclitaxel IV on study Patients undergo magnetic resonance imaging MRI computed tomography CT scan positron emission tomography PET scan andor x-ray imaging throughout the trial Patients also undergo tumor biopsies and blood sample collection during screening and on study
I To assess dose limiting toxicities and determine the recommended phase 2 dose of emavusertib CA--4948 in combination with chemotherapy in patients with pancreatic ductal adenocarcinoma
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity II To evaluate the safety and tolerability of the combination of CA-4948 and chemotherapy
III To determine preliminary signals of efficacy as measured by objective response rate ORR CA-4948 response progression free survival PFS and overall survival OS
EXPLORATORY OBJECTIVES
I To evaluate pharmacodynamic effect of CA-4948 in combination with chemotherapy
II To evaluate pharmacokinetics of CA-4948 in combination with chemotherapy III To explore biomarkers and genomic alterations associated with treatment response
OUTLINE This is a dose-escalation study of CA-4948 in combination with fixed-dose gemcitabine and nab-paclitaxel followed by a dose-expansion study
Patients receive CA-4948 orally PO gemcitabine intravenously IV and nab-paclitaxel IV on study Patients undergo magnetic resonance imaging MRI computed tomography CT scan positron emission tomography PET scan andor x-ray imaging throughout the trial Patients also undergo tumor biopsies and blood sample collection during screening and on study
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-08984 | REGISTRY | None | None |
| 10522 | OTHER | None | None |
| 10522 | OTHER | None | None |
| UM1CA186689 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186689 |