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

COMPLETEDPHASE2

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

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

NCT04617067•Cancer Trials Ireland

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent obtained prior to any study-related procedures.
•2. Incurable recurrent, locally advanced or metastatic pancreatic adenocarcinoma.
•3. Histologically or cytologically confirmed pancreatic adenocarcinoma.
•4. 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.

Exclusion Criteria

•6. Aged 18 years or older
•7. ECOG performance status 0 - 2
•8. 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)
+25 more criteria

Locations (6)

Tallaght University Hospital

Dublin, Dublin 24, Ireland

St. Vincent's University Hospital

Dublin, Dublin 4, Ireland

Beaumont Hospital

Dublin, Dublin 9, Ireland

Cork University Hospital

Cork, Ireland

University Hospital Limerick

Limerick, Ireland

University Hospital Waterford

Waterford, Ireland

Key Dates

Start Date

October 16, 2020

Primary Completion Date

September 30, 2022

Completion Date

September 30, 2022

Last Updated

March 6, 2024

Enrollment

ACTUAL participants

Conditions

Advanced Pancreatic Cancer

Interventions

Paricalcitol

DRUG

Gemcitabine (GEM) and Nab-paclitaxel

DRUG

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

NCT03652428

Locally Advanced Pancreatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

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