Status:
TERMINATED
A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. T...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03300921
Start Date
September 28 2017
End Date
March 23 2022
Last Update
March 31 2022
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104