NCT05365893
PHL Treatment in Pancreatic Cancer
Active, Not Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatmentFox Chase Cancer CenterInvestigator-initiated
~20 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Paricalcitol, Hydroxychloroquine, LosartanNeoadjuvant therapy and surgery only (Control)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who experience grade 3 or greater treatment-related adverse events assessed by CTCAE v5.0
Measured over 4 weeks
Conditions
NCT05365893
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Fox Chase Cancer Center
Philadelphia, Pennsylvaniano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sanjay Reddy, MD, FACS · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
Patients must have new diagnosed histologically or cytologically confirmed pancreatic adenocarcinoma.
Patients must have resectable non-metastatic PDAC and anticipate receiving surgery in a minimum of 4 weeks and a maximum of 12 weeks from completing neoadjuvant chemotherapy and radiation.
Patients are planned for a minimum of 3 months of modified FOLFIRINOX treatment followed by chemo/radiation followed by surgical resection.
Age \> 18 years.
ECOG performance status 0-1
Patients must have normal organ function as defined below
Total bilirubin within normal institutional limits
AST/ALT (SGOT/SGPT) \< 5 times institutional normal limits
Creatinine within normal institutional limits OR
Creatinine clearance \> 30 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal
Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration). Postmenopausal woman must have been amenorrhoeic and nonlactating for at least 12 months to be considered of non-childbearing potential. Men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed.
Ability to understand and willingness to sign a written informed consent and HIPAA consent document
Patients must have resectable non-metastatic PDAC and anticipate receiving surgery in a minimum of 4 weeks and a maximum of 12 weeks from completing neoadjuvant chemotherapy and chemoradiation.
Patients completed a minimum of 3 months of modified FOLFIRINOX treatment followed by chemoradiation prior to study enrollment and plans for surgical resection.
Ability to understand and willingness to sign a written informed consent and HIPAA consent document
Exclusion
Tumors of acinar or adenocarcinoma histology
Patients may not be receiving any other investigational agents
Patients currently receiving hydroxychloroquine or an angiotensin II receptor blocker
Patients with radiological or cytologically confirmed metastatic or unresectable disease
Pregnant or breast feeding. Refer to section 4.4 for further detail.
Patients who have residual grade 3 or higher adverse events from prior chemotherapy or chemoradiotherapy for pancreatic cancer
Concomitant use of an ACE inhibitor or ARB, vitamin D, or hydroxychloroquine. Patient may elect to stop Vitamin D supplement and will be allowed to enroll on the study.
Patients cannot have a history of retinopathy, macular degeneration or other severe ocular issues, baseline hypotension (systolic blood pressure lower than 100 mmHg on two separate readings obtained on two separate days), or history of hypercalcemia requiring treatment
Patients with known disorders precluding use of any of the study drugs including a history of angioedema, hypotension, or renal disease (CrCl \< 30mL/min).
History of allergic reactions attributed to compound of similar chemical or biologic composition to the agent(s) used in this study
Patients receiving any medications or substances that significantly interact with PHL are ineligible (specified in section 5.2).
A marked baseline prolongation of QT/QTc interval
A history of additional risk factors for Torsades de Pointes (e.g., heart failure, family history of Long QT Syndrome)
Atrio-ventricular blockade of 2nd or 3rd degree
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or breast feeding.
What this trial measures
- Number of participants who experience grade 3 or greater treatment-related adverse events assessed by CTCAE v5.04 weeks
Feasibility of administering PHL when given in the window between neoadjuvant chemo-radiotherapy and surgery. Feasibility is defined as the ability to tolerate a minimum of 4 weeks of PHL treatment without interfering with patient's planned surgery.