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

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Terminated

CT.gov ID

NCT03300921

Collaborator

(none)

Enrollment

Location

Arms

53.8

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Paricalcitol	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Arm A: 50mcg IV weekly Arm B: 12mcg PO dailyArm A: 50mcg IV weekly Arm B: 12mcg PO daily

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 28, 2017

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Mar 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Arm A: 50mcg IV weekly	Drug: Paricalcitol Product: Paricalcitol Dose/Route/Regimen: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily
Experimental: Arm B Arm B: 12mcg PO daily	Drug: Paricalcitol Product: Paricalcitol Dose/Route/Regimen: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily

Arm

Intervention/Treatment

Experimental: Arm A

Arm A: 50mcg IV weekly

Drug: Paricalcitol

Product: Paricalcitol Dose/Route/Regimen: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily

Experimental: Arm B

Arm B: 12mcg PO daily

Drug: Paricalcitol

Product: Paricalcitol Dose/Route/Regimen: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily

Outcome Measures

Primary Outcome Measures

Number of Adverse Events [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Peter O'Dwyer, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT03300921

Other Study ID Numbers:

UPCC 26217

First Posted:

Oct 4, 2017

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Mar 31, 2022