Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05827055
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-04-11
Brief Title:
Proglumide and Chemotherapy for Metastatic Pancreatic Cancer
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Role of Cholecystokinin Receptor Blockade on the Tumor Microenvironment in Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProGem
Brief Summary:
This is a Phase 2 study with an open labelled lead-in study to approximately treat 30 patients 6 subjects for Lead-in and 24 for Phase 2 enrolled with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with GEM-NAB-P GEM 1000mgm2 IV and NAB-P 125 mgm2 given days 1 8 and 15 every 28 days and proglumide will be tested at the daily dose of 1200 mg orally given as 400 mg po TID The lead-in study will determine the safety and tolerability of the 1200 mg daily dose of proglumide with standard of care GEM-NAB-P If 0 or 1 of a total of 6 patients at 400mg experiences a DLT then we will proceed to the Phase 2 randomized trial
Detailed Description:
After the Lead-in study in the Phase 2 portion patients will be randomized 11 to standard of care chemotherapy using gemcitabine GEM and nab-paclitaxel NAB-P GEM 1000 mgm2 IV and NAB-P 125 mgm2 given days 1 8 and 15 every 28 days plus placebo or proglumide at the recommended phase 2 dose RP2D for proglumide determined in the Lead-in study Patients will be monitored for safety and toxicity by laboratory blood testing physical examinations neurological check and cardiac monitoring in the Lead-in study Dosing of chemotherapy will be managed following USPI recommendations If dose-related toxicity occurs with proglumide the medication will be held until the AE resolves Proglumide will then be re-administered at the prior lower dose
A research tumor biopsy will be performed before starting therapy Every 8 weeks radiographic imaging will be done for assess tumor burden according to Standard of Care SOC Blood work for safety analysis will be done at 2 weeks then every 4 weeks interim vital signs and history is done every 4 weeks Radiographic imaging and CA19-9 tumor marker will be done every 8 weeks according to SOC A repeat tumor biopsy will be done at week 8 only for research purposes to examine the tumor microenvironment A blood sample for research Biomarkers will be collected before starting therapy and every 8 weeks Patients will be treated for 24 weeks or until progression is documented unacceptable toxicities develop or treatment is no longer required
A research tumor biopsy will be performed before starting therapy Every 8 weeks radiographic imaging will be done for assess tumor burden according to Standard of Care SOC Blood work for safety analysis will be done at 2 weeks then every 4 weeks interim vital signs and history is done every 4 weeks Radiographic imaging and CA19-9 tumor marker will be done every 8 weeks according to SOC A repeat tumor biopsy will be done at week 8 only for research purposes to examine the tumor microenvironment A blood sample for research Biomarkers will be collected before starting therapy and every 8 weeks Patients will be treated for 24 weeks or until progression is documented unacceptable toxicities develop or treatment is no longer required
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 |
|---|---|---|---|
| 01899 | OTHER | Georgetown University | None |