A Study of Entinostat and FOLFOX in Subjects With Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT03760614|
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Cancer||Drug: Entinostat Drug: FOLFOX regimen||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
This will be a modified 3+3 dose-escalation design with a primary endpoint of dose-limiting toxicity. All cohorts will receive the same dose of FOLFOX, once every 2 weeks. All cohorts will receive entinostat on days 1,8, 15, and 22 of 28 day cycles. Cohorts will vary in their dose of entinostat as follows:
Dosing will start with cohort 1. If no dose limiting toxicities (DLTs) are observed, the dose will be escalated directly to cohort 3. If any DLTs are experienced in cohort 1, three additional subjects will be enrolled in cohort 1. If no DLTs are experience by the additional subjects, the dose will be escalated to cohort 2. If a DLT occurs in two subjects in any dose cohort, dose escalation will be halted, and the next three subjects will be enrolled at the next lower dose cohort.
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study of Entinostat and FOLFOX in Subjects With Pancreatic Adenocarcinoma|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2020|
Experimental: Entinostat + FOLFOX
FOLFOX will be administered intravenously (IV), into a vein, using a port-a-cath every 2 weeks. Entinostat will be administered orally on days 1, 8, 15 and 22 of each 28-day cycle. Entinostat dose will vary between 2mg and 5mg depending on time of enrollment and observed toxicities. Dosing will begin at 3mg.
Entinostat will be administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Drug: FOLFOX regimen
FOLFOX will be administered intravenously (IV), into a vein, using a port-a-cath every 2 weeks.
- Dose limiting toxicity (DLT) [ Time Frame: During the first 28 days of treatment ]Dose limiting toxicity (DLT)
- Incidence, nature and severity of adverse events (AE) [ Time Frame: From time of enrollment until completion of the Safety Visit 30 days (+/- 7) days after last dose of entinostat (treatment with entinostat may continue until disease progression, death, unacceptable toxicites or withdrawal, estimated time 6 months) ]Incidence, nature and severity of adverse events (AE)
- Progress free survival (PFS) [ Time Frame: From study entry until disease progress or death from any cause, whichever occurs first (assessed at 6 months) ]Progress free survival (PFS)
- Overall response rate (ORR) [ Time Frame: Through study completion, estimated 1 year ]Overall response rate (ORR) as defined as proportion of patients with complete response (CR) or partial response (PR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760614
|Contact: Thomas Karasic, MDfirstname.lastname@example.org|