Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT03520790 |
Recruitment Status :
Active, not recruiting
First Posted : May 11, 2018
Last Update Posted : January 23, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | April 18, 2018 | ||||
First Posted Date ICMJE | May 11, 2018 | ||||
Last Update Posted Date | January 23, 2024 | ||||
Actual Study Start Date ICMJE | December 5, 2018 | ||||
Actual Primary Completion Date | September 1, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer | ||||
Official Title ICMJE | Vitamin D Receptor Agonist Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Patients With Metastatic Pancreatic Cancer | ||||
Brief 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:
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Detailed Description | Pancreatic cancer is an aggressive disease with treatment options associated with modest benefit, therefore, new treatment options are needed. Paricalcitol 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. Paricalcitol was approved by the Food and Drug Administration (FDA) for the prevention and treatment of elevated calcium levels associated with chronic renal failure. The FDA has not approved paricalcitol as a treatment for pancreatic cancer. This research study is being performed to evaluate the benefit of paricalcitol in combination with gemcitabine and nab-paclitaxel for this disease. The FDA (the U.S. Food and Drug Administration) has approved the combination of gemcitabine and nab-paclitaxel as a treatment option for this disease. Treatment will consists of 4 week treatment cycles. Paricalcitol in the oral formulation will be taken daily, in the intravenous formulation will be administered three times a week. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15. Subjects continue in the study until disease progression, adverse event/toxicity, death or either the subject or sponsor discontinues the study. In this research study, the main objectives include:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Pancreatic Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
36 | ||||
Original Estimated Enrollment ICMJE |
112 | ||||
Estimated Study Completion Date ICMJE | July 1, 2024 | ||||
Actual Primary Completion Date | September 1, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03520790 | ||||
Other Study ID Numbers ICMJE | 18-021 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Kimberly Perez, MD, Dana-Farber Cancer Institute | ||||
Original Responsible Party | Kimberly Perez, Dana-Farber Cancer Institute, Principal Investigator | ||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |