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Advanced Pancreatic CancerPhase 2NCT04617067

Paricalcitol Trial: Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer

A Phase 2 study testing Paricalcitol and Gemcitabine (GEM) and Nab-paclitaxel in people with Advanced Pancreatic Cancer, run by Cancer Trials Ireland at 6 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The trial is designed to establish whether adding a vitamin D analogue, Paricalcitol, to standard chemotherapy treatment, Gemcitabine and Nab-paclitaxel, can improve the outcomes for patients with advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Paricalcitol and Gemcitabine (GEM) and Nab-paclitaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
6 sitesIreland
Study dates
16 Oct 2020to 30 Sep 2022
Phase
Phase 2
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

  • Written informed consent obtained prior to any study-related procedures.
  • Incurable recurrent, locally advanced or metastatic pancreatic adenocarcinoma.
  • Histologically or cytologically confirmed pancreatic adenocarcinoma.
  • No prior chemotherapy for incurable, locally advanced unresectable or metastatic pancreatic cancer. Patients may have received prior chemotherapy in the neo-adjuvant or adjuvant setting provided they have a minimum treatment-free interval of 3 months.
  • At least one measurable lesion according to RECIST criteria (Version 1.1). Patients with bone only disease are not eligible.
  • Aged 18 years or older
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  • ECOG performance status 0 - 2
  • Adequate haematological, renal and hepatic function measured within 28 days prior to commencing study:
  • Total bilirubin ≤ ULN (or ≤ 3 x ULN (≤ grade 2) for patients with liver involvement)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ grade
  • 1) (≤ 5 x ULN for patients with liver involvement by pancreatic cancer).
  • Glomerular filtration rate (GFR) ≥ 30mL/min/1.73 m2 (≤ grade 2) for patients with serum creatinine levels above or below the institutional normal range. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used instead.
  • Platelet count ≥ 100 x 109/L.
  • Haemoglobin (Hb) ≥ 8 g/dL (≤ grade 2)
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≤ grade 1)
  • Corrected serum calcium of ≤ 2.9 mmol/L (≤ grade 1).
  • Life expectancy of at least 12 weeks.
  • Women of childbearing potential and sexually active males must agree to use highly effective contraceptive measures. This applies from starting treatment until at least 6 months after the last study drug administration. The investigator or a designated associate is required to advise the patient how to achieve an adequate birth control. Highly effective contraception is defined in the study as methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include:
  • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable and implantable). iii. Intrauterine device (IUD). iv. Intrauterine hormone-releasing system (IUS). v. Bilateral tubal occlusion. vi. Successfully vasectomised partner. vii. Sexual abstinence.

Who cannot join

  • Treated with other investigational drugs within 28 days or 5.5 half-lives of treatment start; in addition, concurrent alternative (complementary) medications are excluded within 28 days of treatment start.
  • Known brain metastases, unless previously treated and well-controlled for at least 2 months.
  • Dementia, altered mental status, or any other psychiatric condition that would interfere with the patient's safety or informed consent
  • History of other malignancy other than pancreatic cancer. However, patients who have been disease free from another malignancy for at least 5 years, or patients with a history of resected non-melanoma skin cancer or successfully treated in situ cancer and superficial bladder tumours (Ta, Tis, T1) are eligible.
  • Known history of hypercalcaemia.
  • Presence or history of symptomatic kidney stones in the last 5 years.
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  • Active, clinically serious infections > grade 2 (CTCAE v5.0).
  • Greater than or equal to grade 2 sensory or motor neuropathy
  • Uncontrolled intercurrent illness, including, but not limited to uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or social situation that would affect compliance with the requirements of this study.
  • GI tract disease resulting in an inability to take oral medications, malabsorption syndrome, where previous surgical procedures affect absorption and uncontrolled inflammatory bowel disease.
  • History of diseases known to be associated with calcium disorders, including: ongoing hyperparathyroidism and Sarcoidosis.
  • Hypersensitivity to any of the excipients of gemcitabine, Nab-paclitaxel or Paricalcitol.
  • Known vitamin D toxicity
  • Undergoing treatment with the following therapies and medications:
  • Concurrent use of drugs known to influence serum calcium such as thiazide diuretics, teriparatide (recombinant parathyroid hormone), calcitonin and multivitamin supplements containing > 400 IU of vitamin D or calcium.
  • Current use of drugs which could influence bioavailability of paricalcitol (such as magnesium-containing antacids, bile-resin binders).
  • Current use of strong inhibitors of CYP3A4 or CYP2C8.
  • Current use of inducers of CYP3A4 or CYP2C8.
  • Phosphate related medicinal products.
  • Note:
  • Zoledronate or denosumab for patients with bone metastasis is allowed. Note patients with bone only disease are not eligible.
  • Calcium intake is not restricted, but calcium supplementation is not permitted.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Ireland6 sites

  • Cork University Hospital

    Cork, T12 DC4A

  • Tallaght University Hospital

    Dublin, Dublin 24, D24 NR04

  • St. Vincent's University Hospital

    Dublin, Dublin 4, D04 T6F4

  • Beaumont Hospital

    Dublin, Dublin 9, D09V2N0

  • University Hospital Limerick

    Limerick, V94 F858

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

About this study

Official title: Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer

The trial is designed to establish whether adding a vitamin D analogue, Paricalcitol, to standard chemotherapy treatment, Gemcitabine and Nab-paclitaxel, can improve the outcomes for patients with advanced pancreatic cancer.

Read the detailed description

This is an open-label phase II multi-centre single arm study which proposes to test the anti-tumour efficacy of paricalcitol, in combination with GEM/Nab-paclitaxel in patients with advanced metastatic pancreatic cancer.

Being tested
Paricalcitol, Gemcitabine (GEM) and Nab-paclitaxel

What participants receive

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

  • ParicalcitolDrug

    Paricalcitol 12mcg, administered orally on every day of each 28-day cycle.

  • Gemcitabine (GEM) and Nab-paclitaxelDrug

    GEM (at 1,000 mg/m2) and Nab-paclitaxel (at 125 mg/m2 of bodysurface area), administered weekly for 3 of every 4 weeks (on days 1, 8 and 15 only).

Study groups in NCT04617067
Study groupRoleWhat they receive
All PatientsExperimentalOpen Label: Paricalcitol 12mcg once daily, orally every day of each 28 day cycle PLUS GEM (1000mg/m2) and Nab-paclitaxel (Abraxane®) (125mg/m2) on days 1, 8 and 15 of each cycle.
Receives: Drug: Paricalcitol; Drug: Gemcitabine (GEM) and Nab-paclitaxel

What is being measured

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

  1. Progression free survival

    PFS is the percentage of patients free of progression at 24 weeks from registration into the study as determined by radiographic disease assessments per RECIST version 1.1.

    Measured: 24 weeks from registration into the study

  2. Overall survival (OS)

    Overall survival (OS)

    Measured: 18 months post last patient registered

Secondary outcomes (2)

  1. Time to treatment failure

    Time to Treatment Failure (TTF) is defined as time from registration to discontinuation of therapy or add-on of new anti-cancer therapy for any reason (including death, progression and toxicity).

    Measured: 18 months post last patient registered

  2. Tumour response rate Duration of response

    Confirmed tumour response rate as assessed by RECIST criteria version 1.1. Duration of response (DR) as assessed by RECIST criteria version 1.1.

    Measured: 18 months post last patient registered

Timeline

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

  1. First posted5 Nov 2020
  2. Study start16 Oct 2020
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617067
Sponsor's protocol ID
CTRIAL-IE 19-33
Other IDs
2020-000073-24, CTRIAL-IE 19-33
Status last verified
Mar 2024
First submitted
27 Oct 2020
Last updated
6 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Easty D, McDermott R, Murphy AG, Grogan L, Morris PG, Breathnach OS, Egan K, Toomey S, Horgan A, Power D, Osman N, Parker I, Donachie V, Shevlin A, Barrett A, Nolan M, Marron J, Farr CJ, Hennessy BT. Early termination of NCT04617067, a phase II, open label, clinical trial of oral paricalcitol in combination with gemcitabine and NAB-paclitaxel therapy in advanced pancreatic cancer. BMC Cancer. 2026 Jan 15;26(1):255. doi: 10.1186/s12885-025-14512-2.

    PubMed 41535788

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paricalcitol and Gemcitabine (GEM) and Nab-paclitaxel in people with Advanced Pancreatic Cancer, run by Cancer Trials Ireland at 6 sites in Ireland.

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 19 inclusion and 22 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: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Ireland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression free survival (time frame: 24 weeks from registration into the study). 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 NCT04617067, 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 6 Mar 2024.

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