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Pancreatic CancerPhase 1NCT03520790

Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer

A Phase 1 study testing Gemcitabine, Nab-paclitaxel and Paricalcitol in people with Pancreatic Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This research study is a two stage study which consists of a safety run-in phase and a randomized phase 2 study which include subjects with previously-untreated, metastatic pancreatic adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Gemcitabine, Nab-paclitaxel and Paricalcitol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
2 sitesUnited States
Study dates
5 Dec 2018to 1 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histologically-confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma that is metastatic to distant sites.
  • Other histologies such as neuroendocrine and acinar cell carcinoma are excluded. Patients with locally advanced, unresectable disease without distant metastases are excluded.
  • No prior chemotherapy for locally advanced or metastatic pancreatic cancer.
  • Patients are eligible if they received adjuvant treatment after surgical resection with single-agent gemcitabine or gemcitabine plus capecitabine or gemcitabine and nab-paclitaxel or 5-fluorouracil/leucovorin or 5-FU/leucovorin plus irinotecan and oxaliplatin that was completed >12 months before enrollment. Similarly, adjuvant radiation +/- chemosensitization with 5-fluorouracil, capecitabine, or gemcitabine is allowed if completed >12 months before enrollment.
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
  • Age greater than or equal to 18 years.
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  • Patients must have completed any major surgery or open biopsy ≥4 weeks from start of treatment.
  • ECOG performance status ≤1 (see Appendix A)
  • Participants must have normal organ and marrow function as defined below:
  • Absolute neutrophil count ≥1,500/mcL
  • Platelets ≥100,000/mcL
  • Total bilirubin ≤1.5 × institutional upper limit of normal
  • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
  • Calcium (corrected for albumin) * ≤1 × institutional upper limit of normal
  • Creatinine ≤1.5 × institutional upper limit of normal OR
  • Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 × upper limit of normal.
  • Corrected Calcium = serum calcium (mg/dL) + 0.8 (4 - serum albumin (g/dL))
  • Ability to understand and the willingness to sign a written informed consent document.
  • Negative pregnancy testing for women of child bearing age
  • The effects of Paricalcitol, Gemcitabine and nab-Paclitaxel on the developing human fetus are unknown. For this reason and because vitamin D receptor agonist agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of treatment administration

Who cannot join

  • Prior chemotherapy or any other investigational agents for the treatment of locally advanced or metastatic pancreatic cancer
  • Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents.
  • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to paricalcitol, gemcitabine or nab-paclitaxel
  • Pre-existing hypercalcemia, defined as baseline serum calcium (corrected for albumin) above the institutional upper limit of normal.
  • At the time of trial enrollment, vitamin D containing supplements must be stopped and no vitamin D supplements can be taken while the patient is enrolled to the study due to increased risk for hypercalcemia
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  • At the time of trial enrollment, calcium containing supplements must be stopped and no calcium supplements can be taken while the patient is enrolled to the study due to increased risk for hypercalcemia
  • History of symptomatic genitourinary stones (e.g. kidney stones) within the past 12 months
  • History of prior or current synchronous malignancy, except:
  • Malignancy that was treated with curative intent and for which there has been no known active disease for >3 years prior to enrollment
  • Curatively treated non-melanoma skin cancer, cervical cancer in situ, or prostatic intraepithelial neoplasia, without evidence of prostate cancer
  • Pre-existing, clinically significant peripheral neuropathy, defined as CTCAE grade 2 or higher neurosensory or neuromotor toxicity, regardless of etiology
  • Regular use of thiazide diuretics (e.g. hydrochlorothiazide), which can lead to hypercalcemia. Patients must stop these diuretics prior to initiating treatment. Other anti-hypertensive medications can be substituted, as needed.
  • Participants receiving any medications or substances that are inhibitors or inducers of CYP450 3A enzyme(s) are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. [see Appendix D]
  • 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.
  • Participant must be able to swallow and absorb pills.
  • Pregnant women are excluded from this study because Paricalcitol is a vitamin D receptor agonist agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Paricalcitol, breastfeeding should be discontinued if the mother is treated with Paricalcitol. These potential risks may also apply to other agents used in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Vitamin D Receptor Agonist Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Patients With Metastatic Pancreatic Cancer

This research study is a two stage study which consists of a safety run-in phase and a randomized phase 2 study which include subjects with previously-untreated, metastatic pancreatic adenocarcinoma. In the run-in safety study, the safety of adding two formulations (IV or Oral) of paricalcitol to a standard chemotherapy program of gemcitabine and nab-paclitaxel will be evaluated. The randomized phase 2 study will evaluate the efficacy of paricalcitol when added to gemcitabine and nab-paclitaxel

The drugs involved in this study are:

  • Paricalcitol
  • Gemcitabine
  • Nab-paclitaxel
Read the detailed description

Pancreatic cancer is an aggressive disease with treatment options associated with modest benefit, therefore, new treatment options are needed. Paricalcitol is a man-made form of vitamin D. It is thought to work by blocking a signal in the cancer tumor cells that leads to growth and spreading of the tumor. Paricalcitol was approved by the Food and Drug Administration (FDA) for the prevention and treatment of elevated calcium levels associated with chronic renal failure. The FDA has not approved paricalcitol as a treatment for pancreatic cancer. This research study is being performed to evaluate the benefit of paricalcitol in combination with gemcitabine and nab-paclitaxel for this disease.

The FDA (the U.S. Food and Drug Administration) has approved the combination of gemcitabine and nab-paclitaxel as a treatment option for this disease.

Treatment will consists of 4 week treatment cycles. Paricalcitol in the oral formulation will be taken daily, in the intravenous formulation will be administered three times a week. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15.

Subjects continue in the study until disease progression, adverse event/toxicity, death or either the subject or sponsor discontinues the study.

In this research study, the main objectives include:

  • Assess adverse side effects associated with the combination of paricalcitol with gemcitabine and nab-paclitaxel.
  • Evaluate overall survival in patients with pancreatic cancer receiving gemcitabine and nab-paclitaxel with or without paricalcitol.

Phase II was not pursued due to futility based on the results of the NAPOLI-3 therapeutic clinical trial.

Being tested
Gemcitabine, Nab-paclitaxel, Paricalcitol, Placebo
Keywords
Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.

  • Nab-paclitaxelDrug

    Also called Abraxane

    Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.

  • ParicalcitolDrug

    Paricalcitol (IV or oral) is a man-made form of vitamin D. It is thought to work by blocking a signal in the cancer tumor cells that leads to growth and spreading of the tumor.

  • PlaceboOther

    Placebo

Study groups in NCT03520790
Study groupRoleWhat they receive
Gemcitabine + Nab-paclitaxel + PlaceboExperimental* Gemcitabine and Nab-paclitaxel is administered intravenously 3 times/cycle. * Placebo is administered orally on a daily basis
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Other: Placebo
Gemcitabine + Nab-paclitaxel + Paricalcitol IVExperimental* Gemcitabine + Nab-paclitaxel is administered intravenously 3 times/cycle. * Paricalcitol is administered intravenously once weekly.
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Paricalcitol
Gemcitabine + Nab-paclitaxel + Paricalcitol oralExperimental* Gemcitabine + Nab-paclitaxel is administered intravenously 3 times/cycle. * Paricalcitol is administered orally on a daily basis
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Paricalcitol

What is being measured

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

  1. Assess adverse events (per CTCAE v4.0 criteria)

    Assess the adverse events (per CTCAE v4.0 criteria) associated with the addition of paricalcitol to gemcitabine and nab-paclitaxel in phase I participants.

    Measured: 2 years

  2. Overall survival

    Evaluate overall survival (OS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel with or without paricalcitol in phase I/II participants.

    Measured: 2 Years

Secondary outcomes (3)

  1. Assess adverse events (per CTCAE v4.0 criteria)

    Assess the adverse events (per CTCAE v4.0 criteria) associated with the addition of paricalcitol to gemcitabine and nab-paclitaxel in phase II participants.

    Measured: 2 years

  2. Response rate

    Determine the number of patients who demonstrated a clinical response assessed by RECIST criteria on imaging to the combination of paricalcitol with gemcitabine and nab-paclitaxel in phase I/II participants.

    Measured: 2 years

  3. Progression free survival

    Determine the progression free survival derived from the combination of paricalcitol with gemcitabine and nab-paclitaxel in phase I/II participants.

    Measured: 2 years

Timeline

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

  1. First posted11 May 2018
  2. Study start5 Dec 2018
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Why it stopped: Phase II was not pursued due to futility based on the results of the NAPOLI-3 therapeutic clinical trial.

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
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03520790
Sponsor's protocol ID
18-021
Status last verified
Mar 2025
First submitted
18 Apr 2018
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perez KJ, Dias Costa A, Jordan A, Karasic TB, Elganainy D, Kim S, Yuan C, Gui DY, Tan R, Hong SC, Wang X, Cristea S, Coleman E, Truitt M, Oh TG, Zheng H, Furniss CS, Brais L, Bird A, Remland J, Gocheva V, Thalappillil JS, Anderson M, Cleary JM, Enzinger A, Giannakis M, Ng K, Rubinson DA, Schlechter B, Surana R, Singh H, Abrams T, Teitelbaum U, Izgur N, Allen E, Winter PS, Raghavan S, Yeh JJ, Von Hoff D, Liddle C, Downes M, Evans RM, O'Dwyer P, Aguirre A, Nowak JA, Wolpin BM. Gemcitabine and nab-paclitaxel with or without the VDR agonist paricalcitol for metastatic pancreatic cancer: a randomized, multiarm, run-in phase trial. Nat Cancer. 2026 Jun;7(6):928-943. doi: 10.1038/s43018-026-01165-8. Epub 2026 May 25.

    PubMed 42185478

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine, Nab-paclitaxel and Paricalcitol in people with Pancreatic Cancer, run by Dana-Farber Cancer Institute at 2 sites 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 20 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was stopped early (reason given: Phase II was not pursued due to futility based on the results of the NAPOLI-3 therapeutic clinical trial.). Results are not available in the source record.

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?

Assess adverse events (per CTCAE v4.0 criteria) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT03520790, which also lists 1 linked publication.

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 21 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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