A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer

Abramson Cancer Center at Penn Medicine1 site in 1 country3 target enrollmentSeptember 28, 2017

ConditionsPancreatic Cancer

InterventionsParicalcitol

DrugsParicalcitol

Overview

Phase: Phase 1
Intervention: Paricalcitol
Conditions: Pancreatic Cancer
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 3
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal of their tumor. The study will also look at the safety of paricalcitol prior to surgery.

Registry

clinicaltrials.gov

Start Date

September 28, 2017

End Date

March 23, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration.
•Age greater than or equal to 18 years
•Medically fit for surgery in the opinion of the treating surgeon
•Ability to provide written informed consent

Exclusion Criteria

•Patients who are currently pregnant, planning to become pregnant, or breast-feeding.
•Note: women of childbearing potential must agree to use a medically accepted form of birth control including (condoms, diaphragms, cervical cap, an intra-uterine device (IUD), surgical sterility \[tubal ligation or a partner that has undergone a vasectomy\], or oral contraceptives). OR must agree to completely abstain from intercourse for two weeks before beginning study treatment, during participation in this study, and for 2 weeks after the final study treatment
•Patients with hypercalcemia (blood levels greater than 11.5 mg/dL). Note: In patients with GFR 30-60 mL/min by Cockroft-Gault, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol.
•Serum creatinine \> 2.5 x ULN OR GFR \<30 mL/min by Cockroft-Gault formula . Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation.