Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01764477
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2012-12-12
Brief Title:
Safety and Efficacy Study of PRI-724 Plus Gemcitabine in Subjects With Advanced or Metastatic Pancreatic Adenocarcinoma
Sponsor:
Prism Pharma Co Ltd
Organization:
Prism Pharma Co Ltd
Study Overview
Official Title:
Phase Ib Multicenter Cohort Dose Escalation Trial to Determine the Safety Tolerance and Preliminary Antineoplastic Activity of Gemcitabine Administered in Combination With Continuous Intravenous Doses of PRI-724 a CBP β- Catenin Inhibitor to Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Eligible for Second-Line Therapy After Failing First-Line Therapy With FOLFIRINOX or FOLFOX
Status:
COMPLETED
Status Verified Date:
2015-10
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:
None
Brief Summary:
Laboratory studies suggest that the study drug may stop cancer cells from growing by affecting an interaction between proteins in the cells referred to as cAMP-response element-binding protein and ß-catenin
The purpose of this research study is to determine the highest safe dose of study drug that may be used when it is given together with a chemotherapy drug to patients with cancer of the pancreas
The purpose of this research study is to determine the highest safe dose of study drug that may be used when it is given together with a chemotherapy drug to patients with cancer of the pancreas
Detailed Description:
PRI-724 is a small molecule antagonist that binds to the co-activator CBP thereby specifically inhibiting the subset of Wntβ-catenin-driven genes that are up-regulated in cancer cells PRI-724 is being developed as a potential antineoplastic agent
Purpose
To determine the safety tolerability dose-limiting toxicities DLTs and maximum tolerated dose MTD of sequential escalating doses per cohort of PRI-724 administered in combination with gemcitabine to patients with adenocarcinoma of the pancreas that is locally advanced metastatic or otherwise inoperable who are candidates for second-line therapy after failing first-line therapy with FOLFIRINOX ie folinic acid leucovorin fluorouracil irinotecan oxaliplatin
PRI-724 320 640 905 mgm2day continuous intravenous CIV infusion over 24 h daily 7 days 1 week on with 1 week recovery 2 4 weeks equals 1 cycle
Gemcitabine 1000 mgm2 IV over 30 minutes 3 weeks on with 1 week recovery 4 weeks equals 1 cycle
Patients with documented measurable or evaluable adenocarcinoma of the pancreas that is locally advanced metastatic or otherwise inoperable who are candidates for second-line therapy after failing first-line therapy with FOLFIRINOX will be entered into this phase 1b multicenter open-label non-randomized dose-escalation per cohort study The trial is designed to evaluate the safety tolerability DLTs and MTD of escalating doses of PRI-724 a CBP β- catenin inhibitor when administered in combination with a standard dose of gemcitabine Correlative studies include characterization of the PK profiles of PRI-724 and gemcitabine evaluation of the utility of potential PD markers of PRI-724 activity as well as preliminary assessment of the antineoplastic activity of PRI-724 plus gemcitabine in this patient population
Purpose
To determine the safety tolerability dose-limiting toxicities DLTs and maximum tolerated dose MTD of sequential escalating doses per cohort of PRI-724 administered in combination with gemcitabine to patients with adenocarcinoma of the pancreas that is locally advanced metastatic or otherwise inoperable who are candidates for second-line therapy after failing first-line therapy with FOLFIRINOX ie folinic acid leucovorin fluorouracil irinotecan oxaliplatin
PRI-724 320 640 905 mgm2day continuous intravenous CIV infusion over 24 h daily 7 days 1 week on with 1 week recovery 2 4 weeks equals 1 cycle
Gemcitabine 1000 mgm2 IV over 30 minutes 3 weeks on with 1 week recovery 4 weeks equals 1 cycle
Patients with documented measurable or evaluable adenocarcinoma of the pancreas that is locally advanced metastatic or otherwise inoperable who are candidates for second-line therapy after failing first-line therapy with FOLFIRINOX will be entered into this phase 1b multicenter open-label non-randomized dose-escalation per cohort study The trial is designed to evaluate the safety tolerability DLTs and MTD of escalating doses of PRI-724 a CBP β- catenin inhibitor when administered in combination with a standard dose of gemcitabine Correlative studies include characterization of the PK profiles of PRI-724 and gemcitabine evaluation of the utility of potential PD markers of PRI-724 activity as well as preliminary assessment of the antineoplastic activity of PRI-724 plus gemcitabine in this patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None