AzTrials
AzTrials

Pancreatic Ductal AdenocarcinomaEarly Phase 1NCT05365893

PHL Treatment in Pancreatic Cancer

A Early Phase 1 study testing Paricalcitol, Hydroxychloroquine, Losartan in people with Pancreatic Ductal Adenocarcinoma, run by Fox Chase Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This proposal will investigate the effect of paricalcitol, hydroxychloroquine, and losartan (PHL) combination of 3 stroma-modifying drugs on pancreatic adenocarcinoma and its stroma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
Paricalcitol, Hydroxychloroquine, Losartan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
20 Oct 2021to 31 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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.
  • Inclusion criteria for participation in experimental PHL therapy (Arm A):
Show all 21Show fewer
  • 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 Criteria for participation in Experimental PHL Therapy (Arm A):
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: Window of Opportunity for Neoadjuvant Stroma Modification in Pancreatic Cancer

This proposal will investigate the effect of paricalcitol, hydroxychloroquine, and losartan (PHL) combination of 3 stroma-modifying drugs on pancreatic adenocarcinoma and its stroma.

Read the detailed description

This study will test the feasibility and safety of these pancreatic ductal adenocarcinoma (PDAC) stroma modulators in the pre-operative setting, and will offer the opportunity to detect the combined effect on PDAC tissue constituents to validate the mechanism using real-time biologic end points. The long-term goal for PHL is to deploy this regimen in combination with chemotherapy to treat PDAC. Further, this study will establish a paradigm of a "window" trial (the use of novel therapies in the period of time between the end of neoadjuvant treatment and surgery) to test new compounds and establish their biological activities in PDAC.

This pilot trial will establish the feasibility and determine the biological activity of PHL combination given prior to surgery to 10 patients who completed neoadjuvant therapy (NAT) with modified FOLFIRINOX and chemoradiation using sequential blood and tissue samples (blood samples will be collected pre NAT and post chemotherapy; post chemoradiation; pre-surgery and post-surgery) and compare with 10 patients who undergo the same neoadjuvant therapy (modified FOLFIRINOX followed by chemo-RT and proceed to surgery without treatment with PHL regimen (blood sample in this group will be collected pre NAT and post-chemotherapy; post-chemoradiation, pre-surgery and post-surgery).

This is a single site pilot study of PHL in patients with resectable non-metastatic PDAC.

Study will enroll 20 patients who will be consented prior to initiation of NAT to donate blood (pre NAT, post neoadjuvant chemotherapy and post neoadjuvant radiation and pre and post-surgery) and tissue (archival tissue from diagnosis biopsy and surgical specimen). All patients will complete a minimum of 3 months of modified FOLFIRINOX + chemoradiation. Of these 20 patients, 10 will receive the study PHL regimen (Arm A) and 10 will serve as the control arm (Arm B).

10 patients will be treated with resectable non-metastatic PDAC with a combination of three stroma-modifying agents PHL during the "window of opportunity", spanning 4-8 weeks after conclusion of neoadjuvant chemotherapy plus radiation and prior to surgery (Fig 1). Neoadjuvant chemotherapy will consist of at least 3 months of modified FOLFIRINOX regimen followed by chemoradiotherapy. The choice of chemotherapy given concurrently with radiation will be at the discretion of the medical team and the patient. Patients should start on the trial medications at least 4 weeks prior to surgery and continue to take the medication until the day before surgery. All the patients in the treatment arm must receive PHL for a minimum of 4 weeks and for a maximum period of 8 weeks. Patients who discontinue before completing 4 weeks of therapy due to disease progression may be replaced.

Being tested
Paricalcitol, Hydroxychloroquine, Losartan, Neoadjuvant therapy and surgery only (Control)
Keywords
chemo-resistant cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paricalcitol, Hydroxychloroquine, LosartanCombination product

    Paricalcitol 25 mcg IV administered M-W-F Hydroxychloroquine 600 mg PO BID Losartan 50 mg PO daily

  • Neoadjuvant therapy and surgery only (Control)Other

    Control arm These patients will proceed to surgery at completion of neoadjuvant therapy.

Study groups in NCT05365893
Study groupRoleWhat they receive
PHL (Paricalcitol, Hydroxychloroquine, Losartan)ExperimentalParicalcitol 25 mcg IV administered M-W-F Hydroxychloroquine 600 mg PO BID Losartan 50 mg PO daily
Receives: Combination Product: Paricalcitol, Hydroxychloroquine, Losartan
Neoadjuvant therapy and surgery only (Control)Active comparatorControl arm These patients will proceed to surgery at completion of neoadjuvant therapy.
Receives: Other: Neoadjuvant therapy and surgery only (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who experience grade 3 or greater treatment-related adverse events assessed by CTCAE v5.0

    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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start20 Oct 2021
  3. Primary completion18 Dec 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
20 patients diagnosed with resectable pancreatic cancer will be consented for blood and tissue prior to starting neoadjuvant therapy. 10 patients will be assigned to the experimental (PHL) arm (Arm A). Treatment arm; N=10 (Consented for PHL the time of neoadjuvant therapy completion): Experimental therapy 4-8 weeks pre-op: Paricalcitol 25 mcg IV administered M-W-F Hydroxychloroquine 600 mg PO BID Losartan 50 mg PO daily Control arm (Arm B); N=10 These patients have already signed consent for blood and tissue- will proceed to surgery at completion of neoadjuvant therapy.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365893
Sponsor's protocol ID
20-1085
Other IDs
GI-174, 1R21CA252535-01A1
Status last verified
May 2026
First submitted
4 Nov 2021
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Paricalcitol, Hydroxychloroquine, Losartan in people with Pancreatic Ductal Adenocarcinoma, run by Fox Chase Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who experience grade 3 or greater treatment-related adverse events assessed by CTCAE v5.0 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05365893.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in