Trial reportBMC cancer2026
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.
Trial report in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04617067 (Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer), which is not on this map. Cited by 2 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer
Who cites it
2 citing papers in PubMed.
- Co-Clinical Evaluation of Synthetic Vitamin D and Chemotherapy in Pancreatic Cancer by Integrated Imaging and Molecular Analyses.Cancer research communications · 2026Trial
- Nanomaterials targeting cancer-associated fibroblasts to overcome stromal barriers in cancer immunotherapy.Journal of nanobiotechnology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPancreatic cancer (PDAC) often responds poorly to chemotherapy, represents an unmet clinical need and new therapeutic approaches are urgently required. Desmoplasia is a hallmark of PDAC. Multiple preclinical studies suggest cancer associated fibroblasts (CAF) support cancer growth, and attention has recently turned towards inclusion of anti-stromal agents into chemotherapy trials. Our objective was to evaluate safety and tolerability of oral paricalcitol in combination with systemic chemotherapy in patients with advanced PDAC.
methodsThis was a phase II, single-arm study in patients with advanced PDAC who had received no prior systemic chemotherapy. Gemcitabine and NAB-paclitaxel were administered weekly for 3 of every 4 weeks (days 1, 8 and 15) and paricalcitol administered orally every day of a 28-day cycle. Patients were treated until disease progression with an interim analysis. The primary efficacy endpoint was progression free survival (PFS). Secondary efficacy endpoints were evaluation of overall survival (OS), time to treatment failure (TTF) and tumour response rate (TRR).
resultsFifteen patients were enrolled. Median PFS was 14.6 weeks with 95% CI of (7.9–24.0). Estimated PFS rate at 24 weeks was 18.0% with 95% CI of (2.9–43.4). Five patients achieved stable disease; one achieved a partial response. Confirmed tumour response rate was 8.3% with 90% CI of (0.4–33.9). Mild hypercalcaemia, previously associated with vitamin D receptor agonists, occurred in nine (60%) patients, moderate (Grade 3) hypercalcaemia in 2 patients and there was no grade 4/5 hypercalcaemia. The study did not meet its primary objective and discontinued following interim analysis.
conclusionsOral paricalcitol was safely combined with chemotherapy. The prespecified efficacy threshold for 6-month progression free survival probability (≥ 70%) was not met. The study was stopped early after the planned interim analysis as the criterion pre-specified in order to move to the next stage of the study was not met. Efficacy of paricalcitol in advanced PDAC was lower than expected, with a non-significant trend towards decreased PFS. Our study has implications for interpretation and design of clinical trials incorporating paricalcitol for patients with advanced pancreatic cancer.
trial registrationClinicalTrials.gov identifier: NCT04617067, registration date 10/27/2020.
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