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

Phase 1

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: Paricalcitol

• Registration Number: NCT03300921
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-28
• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-09-29
• Study First Posted: 2017-10-04
• Primary Completion: 2020-08-30
• Status Verified: 2022-03
• Study Completion: 2022-03-23
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Paricalcitol	Arm B: 12mcg PO daily
Arm A	Paricalcitol	Arm A: 50mcg IV weekly

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	18 months

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States