NCT04617067

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

October 27, 2020

Last Update Submit

March 4, 2024

Conditions

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    24 weeks from registration into the study

  • Overall survival (OS)

    Overall survival (OS)

    18 months post last patient registered

Secondary Outcomes (2)

  • Time to treatment failure

    18 months post last patient registered

  • Tumour response rate Duration of response

    18 months post last patient registered

Other Outcomes (2)

  • Safety and tolerability

    18 months post last patient registered

  • Incidence of hypercalcaemia

    18 months post last patient registered

Study Arms (1)

All Patients

EXPERIMENTAL

Open 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.

Drug: ParicalcitolDrug: Gemcitabine (GEM) and Nab-paclitaxel

Interventions

ParicalcitolDRUG

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

All Patients
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).

All Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • \) (≤ 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)
  • +4 more criteria

You may not qualify if:

  • 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.
  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tallaght University Hospital

Dublin, Dublin 24, D24 NR04, Ireland

Location

St. Vincent's University Hospital

Dublin, Dublin 4, D04 T6F4, Ireland

Location

Beaumont Hospital

Dublin, Dublin 9, D09V2N0, Ireland

Location

Cork University Hospital

Cork, T12 DC4A, Ireland

Location

University Hospital Limerick

Limerick, V94 F858, Ireland

Location

University Hospital Waterford

Waterford, X91 ER8E, Ireland

Location

MeSH Terms

Interventions

paricalcitolGemcitabine130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Prof. Bryan Hennessy

    Beaumont Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 5, 2020

Study Start

October 16, 2020

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

IE(6)