Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic… (NCT04054362) | Clinical Trial Compass
CompletedPhase 2
Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
United Kingdom27 participantsStarted 2018-11-29
Plain-language summary
This is a phase II pilot trial of Paclitaxel Protein Bound and Gemcitabine based chemotherapy and the addition of Paricalcitol upon attainment of stable or progressive disease in eligible patients with untreated metastatic pancreatic ductal adenocarcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide written informed consent.
✓. At least one lesion that can be measured accurately at baseline as ≥10mm in the longest diameter (except lymph nodes which must have a short axis ≥15mm) with CT/MRI and which is suitable for repeated measurements per RECIST v1.1
✓. Adequate haematological and end-organ function, as per the local institutions reference ranges, within 21 days prior to day 1 of cycle 1 of treatment defined by the following:
✓. Haematology: ANC \>1.5 x 109/L (\>1500 cells / mm3); Platelet count \> 100 x 109/L (\>100,000 cells/mm3); haematocrit level \>27% for females or \>30% for males
Exclusion criteria
✕. Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. In exceptional circumstances, if a patient has received paclitaxel protein bound and gemcitabine as first line chemotherapy for metastatic disease in exactly the same way as mandated in the current trial, they can be considered eligible to be enrolled directly to the add on paricalcitol component of the trial.
What they're measuring
1
Clinical benefit
Timeframe: Time frame will be measured from date of Paricalcitol until the date of documented progression or date of death from any cause, whichever came first, expected maximum length of 7 months.
✕. Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
✕. Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
✕. Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 28 days of Cycle 1 Day 1).
✕. History of other malignancies (except cured basal or squamous cell carcinoma, superficial bladder cancer, prostate cancer in active surveillance, or carcinoma in situ of the cervix) unless documented free of cancer for ≥2 years.
✕. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
✕. History of HIV infection.
✕. Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or anti-fungals (see Section 6.10).