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Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer

NCT03520790 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-03-21

No results posted yet for this study

Summary

This research study is a two stage study which consists of a safety run-in phase and a randomized phase 2 study which include subjects with previously-untreated, metastatic pancreatic adenocarcinoma. In the run-in safety study, the safety of adding two formulations (IV or Oral) of paricalcitol to a standard chemotherapy program of gemcitabine and nab-paclitaxel will be evaluated. The randomized phase 2 study will evaluate the efficacy of paricalcitol when added to gemcitabine and nab-paclitaxel

The drugs involved in this study are:

* Paricalcitol
* Gemcitabine
* Nab-paclitaxel

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.

DRUG

Nab-paclitaxel

Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.

DRUG

Paricalcitol

Paricalcitol (IV or oral) is a man-made form of vitamin D. It is thought to work by blocking a signal in the cancer tumor cells that leads to growth and spreading of the tumor.

OTHER

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Kimberly Perez, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2024-07-01
Completion
2024-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03520790 on ClinicalTrials.gov