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

NCT03300921 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: UPCC 26217
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  18 months

Study Arms (2)

Arm A

EXPERIMENTAL

Arm A: 50mcg IV weekly

Drug: Paricalcitol

Arm B

EXPERIMENTAL

Arm B: 12mcg PO daily

Drug: Paricalcitol

Interventions

Paricalcitol DRUG

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

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Peter O'Dwyer, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: September 28, 2017
• Primary Completion: August 30, 2020
• Study Completion: March 23, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

US (1)