Pancreatic CancerPhase 2NABPLAGEMDNCT03415854
Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD)
A Phase 2 study testing Paricalcitol (Zemplar) in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by HonorHealth Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if the combination of paclitaxel protein bound, gemcitabine, cisplatin, paricalcitol are effective in individuals with previously untreated metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Pancreatic Adenocarcinoma
- What is being tested?
- Paricalcitol (Zemplar)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 11 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years of age; male or female.
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- Capable of providing informed consent and complying with trial procedures including obtaining paired biopsies during therapy
- Karnofsky Performance Status (KPS) of ≥ 70%.
- Life expectancy ≥ 12 weeks.
- Measurable tumor lesions according to RECIST 1.1 criteria.
- Women must agree not to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study and until 90 days after last dose of study treatment. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.
Who cannot join
- 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 Fluorouracil (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.
- 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 4 weeks of Screening Visit).
- 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.
- Laboratory values: Screening serum creatinine >1.5 mg/dL; total bilirubin > (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5x ULN or ≥ 5.0×ULN if liver metastases are present; absolute neutrophil count <1,500/mm3, platelet concentration <100,000/mm3, hematocrit level <27% for females or <30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) >1.5×ULN unless on anticoagulation agents.
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- 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.
- Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.
Trial locations and contacts
1 site in 1 country.
United States1 site
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: A Phase II Pilot Trial Of Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and the Addition Of Paricalcitol Upon Disease Progression in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NABPLAGEMD)
The purpose of this study is to determine if the combination of paclitaxel protein bound, gemcitabine, cisplatin, paricalcitol are effective in individuals with previously untreated metastatic pancreatic cancer.
Read the detailed description
Pancreatic cancer continues to be a highly lethal disease with an overall 5 year survival of only 8%. Since 2004, the incidence of pancreatic cancer has been increasing by 1.5% per year and it is estimated that there will be 53,670 new cases diagnosed in the United States in 2017, with 43,090 expected deaths. Pancreatic cancer is the third most common cause of cancer-related deaths in both men and women, and the incidence is about equal in both sexes. Of all types of pancreatic cancers, pancreatic ductal adenocarcinoma (PDA) is by far the most common, representing 80% of cases. Due to lack of adequate screening techniques, greater than 80% of patients at the time of diagnosis present with unresectable, advanced disease. Standard treatment options for inoperable patients with locally advanced and metastatic PDA have been quite limited. Gemcitabine monotherapy, approved by the Food and Drug Administration (FDA) in 1996, demonstrated a median survival of 5.7 months, and has been the mainstay in treating patients with PDA. The first combination regimen to demonstrate any survival benefit compared with gemcitabine alone was gemcitabine plus erlotinib, with median survival of 6.24 months versus 5.91 months for single agent gemcitabine.
A meta-analysis of randomized trials by Heinemann and colleagues showed that patients with advanced pancreatic cancer and a good performance status may benefit from combination chemotherapy with gemcitabine plus a platinum agent or a fluoropyrimidine. Multiple combination regimens are being utilized.
Recently, the regimen of 5-fluorouracil/leucovorin/irinotecan/oxaliplatin (FOLFIRINOX) compared with gemcitabine demonstrated improvement in both progression-free survival (PFS, 6.4 vs. 3.3 months) and overall survival (OS, 11.1 vs. 6.8 months) for patients with a good performance status. FOLFIRINOX, however, is associated with substantial grade 3 and 4 toxicities, including diarrhea, nausea, vomiting, fatigue, neutropenia and febrile neutropenia, and cannot be given to patients >76 years of age or in some cases patients with head of the pancreas tumors. An international phase III trial comparing paclitaxel protein bound (now called paclitaxel protein bound) plus gemcitabine to gemcitabine single agent demonstrated a statistically significant improvement in OS (8.5 vs. 6.7 months) for advanced pancreatic cancer patients using the gemcitabine and paclitaxel protein bound over gemcitabine alone.
A recently completed phase Ib/II trial of the combination of paclitaxel protein bound plus gemcitabine plus cisplatin in previously untreated stage IV pancreatic adenocarcinoma patients was presented at the 2017 Gastrointestinal Cancer Symposium. In 24 patients with stage IV pancreatic cancer they reported 8.3% complete response (CR), 62.5% partial response (PR), 16.7% stable disease and 12.5% progressive disease. The rationale for adding cisplatin to paclitaxel protein bound and gemcitabine is that in a study of 1,029 patients whose pancreatic cancer tumors underwent molecular profiling, 57% of these tumors were negative for expression of the excision repair cross-complementation group 1 (ERCC1), indicating sensitivity to a platinum anti-tumor agent. In addition to the above, in our whole genome/transcriptome sequencing analysis, we found that abnormal repair pathways were a feature of all of the pancreatic cancers that were sequenced. Cisplatin prevents cellular deoxyribonucleic acid (DNA) repair by binding to and causing crosslinking of DNA, triggering apoptosis. Cisplatin has been used in other combination regimens to treat patients with PDA. For example, the cisplatin, epirubicin, 5-fluorouracil and gemcitabine (PEFG) regimen had an acceptable toxicity profile and was associated with a 24% partial response rate, 5 month PFS and 8.3 month OS as second line therapy.
Most recently, a study showed that Vitamin D can change the pancreatic tumor microenvironment from an immunologically suppressive (tumor promoting) one to an immunologically hostile one (e.g. decreased IL-6, decreased CXCL12 etc.). In addition, in the same study, the vitamin D ligand calcipotriol decreased production of collagen, decreased myeloid derived suppressor cells (MDSCs) and decreased regulatory T cells. Remarkably, in clinical practice, the vitamin D analogue paricalcitol was observed to reverse chemotherapy resistance. Two individuals with pancreatic adenocarcinoma who were receiving paclitaxel protein bound and gemcitabine based combination chemotherapy developed progressive disease which was reversed by the addition of paricalcitol.
Based upon these promising clinical and pre-clinical data we are initiating a clinical trial combining paclitaxel protein bound, gemcitabine, and cisplatin for patients with metastatic PDA. When these patients develop progressive disease the vitamin D analog paricalcitol will be added to the regimen. The treatment will continue until further disease progression.
- Conditions
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreas Metastases, Adenocarcinoma
- Being tested
- Paricalcitol (Zemplar)
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paricalcitol (Zemplar)Drug
Also called Cisplatin (Platinol), Paclitaxel Protein Bound (Abraxane), Gemcitabine (Gemzar)
combination therapy
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol (Zemplar) | Experimental | Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Receives: Drug: Paricalcitol (Zemplar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response (BOR)
Best overall response (BOR) is defined as the best tumor response recorded 9 weeks after treatment initiation Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1). Responses are categorized as: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; stable disease (SD), no change in target lesion size; and progressive disease (PD), ≥20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. MRI completed every 3 cycles of treatment to determine if the tumor responded to treatment. A confirmatory positron emission tomography (PET) scan could be ordered to confirm CR.
Measured: From enrollment until the end of 3+ treatment cycles (each cycle is 21 days), up to 190 days.
Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time from starting paricalcitol until disease progression. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a ≥20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From start of paricalcitol to disease progression, up to 7 months
Overall Survival (OS)
Overall survival (OS) is defined as the length of time that patients remained alive after starting paricalcitol treatment.
Measured: From start of paricalcitol through follow-up, up to 16.5 months
Secondary outcomes (2)
Serum Levels of Carbohydrate Antigen 19-9 (CA19-9)
Carbohydrate antigen 19-9 (CA 19-9) is a validated serum biomarker for pancreatic cancer tumor burden used to monitor treatment response. Serum CA19-9 values were measured after each cycle of treatment to identify if they normalized over time. The median beta coefficient (slope of the regression line) among CA 19-9 expressing participants in a linear mixed effects model of log-transformed CA 19-9 is reported here. A positive beta coefficient is associated with increasing CA 19-9 levels over time (higher tumor burden; no treatment response), while a negative beta coefficient is associated with decreasing CA 19-9 levels over time (lower tumor burden; treatment response).
Measured: At the end of each treatment cycle (each cycle is 21 days), up to 30 weeks.
Adverse Events Possibly Related to Paricalcitol
The number of patients who experienced an adverse event (AE) determined to be possibly related to the study treatment of paricalcitol. Adverse events occurring were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Grade refers to the severity of the AE and are given on a 1-5 scale, with each scale having unique clinical descriptions of severity for each AE based on this general guideline:
- Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
- Grade 2: Moderate; minimal, local or noninvasive intervention indicated
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling
- Grade 4: Life-threatening consequences; urgent intervention indicated.
- Grade 5: Death related to AE.
Measured: From enrollment through 30 days after last paricalcitol treatment, up to 16.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start31 Jan 2018
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Barts Cancer Institute, Abramson Cancer Center at Penn Medicine, Salk Institute for Biological Studies, Mayo Clinic, Princeton University, Imaging Endpoints, Translational Genomics Research Institute, Stand Up To Cancer, Cancer Research UK, Lustgarten Foundation, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Erkut Borazanci, MD, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415854
- Sponsor's protocol ID
- SU2C HRI NPG-001
- Acronym
- NABPLAGEMD
- Status last verified
- Dec 2023
- First submitted
- 9 Jan 2018
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: If the study site is a 'covered site' under the definitions of the Health Insurance Portability and Accounting Act (HIPAA), the Investigator will ensure that the patient consents to the use of data by HonorHealth and its designees for the purposes of regulatory submissions, study publications, and drug approval. Stand Up To Cancer (SU2C) will be notified of any outputs of the research such as guidelines, publications, presentation, changes in service delivery etc. prior to external submission or presentation. In any oral or written report or poster presentation of Results or otherwise relating to the Research, the support of Cancer Research UK (CRUK), SU2C and the Lustgarten foundation will be acknowledged, displaying the relevant logs where possible. Any publications resulting from research funded in whole or in part by the Grant must be cited as required per signed confidentiality agreements.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Trial Of Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and the Addition Of Paricalcitol Upon Disease Progression in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NABPLAGEMD)
- ClinicalTrials.gov ID
- NCT03415854
- Acronym / sponsor ID
- NABPLAGEMD / SU2C HRI NPG-001
- Conditions
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreas Metastases, Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Collaborators
- Barts Cancer Institute, Abramson Cancer Center at Penn Medicine, Salk Institute for Biological Studies, Mayo Clinic, Princeton University, Imaging Endpoints, Translational Genomics Research Institute, Stand Up To Cancer, Cancer Research UK, Lustgarten Foundation, University of California, San Diego
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the combination of paclitaxel protein bound, gemcitabine, cisplatin, paricalcitol are effective in individuals with previously untreated metastatic pancreatic cancer.
Detailed description
Pancreatic cancer continues to be a highly lethal disease with an overall 5 year survival of only 8%. Since 2004, the incidence of pancreatic cancer has been increasing by 1.5% per year and it is estimated that there will be 53,670 new cases diagnosed in the United States in 2017, with 43,090 expected deaths. Pancreatic cancer is the third most common cause of cancer-related deaths in both men and women, and the incidence is about equal in both sexes. Of all types of pancreatic cancers, pancreatic ductal adenocarcinoma (PDA) is by far the most common, representing 80% of cases. Due to lack of adequate screening techniques, greater than 80% of patients at the time of diagnosis present with unresectable, advanced disease. Standard treatment options for inoperable patients with locally advanced and metastatic PDA have been quite limited. Gemcitabine monotherapy, approved by the Food and Drug Administration (FDA) in 1996, demonstrated a median survival of 5.7 months, and has been the mainstay in treating patients with PDA. The first combination regimen to demonstrate any survival benefit compared with gemcitabine alone was gemcitabine plus erlotinib, with median survival of 6.24 months versus 5.91 months for single agent gemcitabine.
A meta-analysis of randomized trials by Heinemann and colleagues showed that patients with advanced pancreatic cancer and a good performance status may benefit from combination chemotherapy with gemcitabine plus a platinum agent or a fluoropyrimidine. Multiple combination regimens are being utilized.
Recently, the regimen of 5-fluorouracil/leucovorin/irinotecan/oxaliplatin (FOLFIRINOX) compared with gemcitabine demonstrated improvement in both progression-free survival (PFS, 6.4 vs. 3.3 months) and overall survival (OS, 11.1 vs. 6.8 months) for patients with a good performance status. FOLFIRINOX, however, is associated with substantial grade 3 and 4 toxicities, including diarrhea, nausea, vomiting, fatigue, neutropenia and febrile neutropenia, and cannot be given to patients >76 years of age or in some cases patients with head of the pancreas tumors. An international phase III trial comparing paclitaxel protein bound (now called paclitaxel protein bound) plus gemcitabine to gemcitabine single agent demonstrated a statistically significant improvement in OS (8.5 vs. 6.7 months) for advanced pancreatic cancer patients using the gemcitabine and paclitaxel protein bound over gemcitabine alone.
A recently completed phase Ib/II trial of the combination of paclitaxel protein bound plus gemcitabine plus cisplatin in previously untreated stage IV pancreatic adenocarcinoma patients was presented at the 2017 Gastrointestinal Cancer Symposium. In 24 patients with stage IV pancreatic cancer they reported 8.3% complete response (CR), 62.5% partial response (PR), 16.7% stable disease and 12.5% progressive disease. The rationale for adding cisplatin to paclitaxel protein bound and gemcitabine is that in a study of 1,029 patients whose pancreatic cancer tumors underwent molecular profiling, 57% of these tumors were negative for expression of the excision repair cross-complementation group 1 (ERCC1), indicating sensitivity to a platinum anti-tumor agent. In addition to the above, in our whole genome/transcriptome sequencing analysis, we found that abnormal repair pathways were a feature of all of the pancreatic cancers that were sequenced. Cisplatin prevents cellular deoxyribonucleic acid (DNA) repair by binding to and causing crosslinking of DNA, triggering apoptosis. Cisplatin has been used in other combination regimens to treat patients with PDA. For example, the cisplatin, epirubicin, 5-fluorouracil and gemcitabine (PEFG) regimen had an acceptable toxicity profile and was associated with a 24% partial response rate, 5 month PFS and 8.3 month OS as second line therapy.
Most recently, a study showed that Vitamin D can change the pancreatic tumor microenvironment from an immunologically suppressive (tumor promoting) one to an immunologically hostile one (e.g. decreased IL-6, decreased CXCL12 etc.). In addition, in the same study, the vitamin D ligand calcipotriol decreased production of collagen, decreased myeloid derived suppressor cells (MDSCs) and decreased regulatory T cells. Remarkably, in clinical practice, the vitamin D analogue paricalcitol was observed to reverse chemotherapy resistance. Two individuals with pancreatic adenocarcinoma who were receiving paclitaxel protein bound and gemcitabine based combination chemotherapy developed progressive disease which was reversed by the addition of paricalcitol.
Based upon these promising clinical and pre-clinical data we are initiating a clinical trial combining paclitaxel protein bound, gemcitabine, and cisplatin for patients with metastatic PDA. When these patients develop progressive disease the vitamin D analog paricalcitol will be added to the regimen. The treatment will continue until further disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol (Zemplar) | Experimental | Drug: Paricalcitol (Zemplar)Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years of age; male or female.
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- Capable of providing informed consent and complying with trial procedures including obtaining paired biopsies during therapy
- Karnofsky Performance Status (KPS) of ≥ 70%.
- Life expectancy ≥ 12 weeks.
Key exclusion criteria (10 listed)
- 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 Fluorouracil (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.
- 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 4 weeks of Screening Visit).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paricalcitol (Zemplar)Also: Cisplatin (Platinol), Paclitaxel Protein Bound (Abraxane), Gemcitabine (Gemzar)combination therapy | Drug | Paricalcitol (Zemplar) |
Primary outcome
Best Overall Response (BOR)
Time frame: From enrollment until the end of 3+ treatment cycles (each cycle is 21 days), up to 190 days.
Best overall response (BOR) is defined as the best tumor response recorded 9 weeks after treatment initiation Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1). Responses are categorized as: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; stable disease (SD), no change in target lesion size; and progressive disease (PD), ≥20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. MRI completed every 3 cycles of treatment to determine if the tumor responded to treatment. A confirmatory positron emission tomography (PET) scan could be ordered to confirm CR.
Progression-free Survival (PFS)
Time frame: From start of paricalcitol to disease progression, up to 7 months
Progression-free survival (PFS) is defined as the time from starting paricalcitol until disease progression. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a ≥20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall Survival (OS)
Time frame: From start of paricalcitol through follow-up, up to 16.5 months
Overall survival (OS) is defined as the length of time that patients remained alive after starting paricalcitol treatment.
2 secondary outcomes
Serum Levels of Carbohydrate Antigen 19-9 (CA19-9)
Time frame: At the end of each treatment cycle (each cycle is 21 days), up to 30 weeks.
Adverse Events Possibly Related to Paricalcitol
Time frame: From enrollment through 30 days after last paricalcitol treatment, up to 16.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. If the study site is a 'covered site' under the definitions of the Health Insurance Portability and Accounting Act (HIPAA), the Investigator will ensure that the patient consents to the use of data by HonorHealth and its designees for the purposes of regulatory submissions, study publications, and drug approval. Stand Up To Cancer (SU2C) will be notified of any outputs of the research such as guidelines, publications, presentation, changes in service delivery etc. prior to external submission or presentation. In any oral or written report or poster presentation of Results or otherwise relating to the Research, the support of Cancer Research UK (CRUK), SU2C and the Lustgarten foundation will be acknowledged, displaying the relevant logs where possible. Any publications resulting from research funded in whole or in part by the Grant must be cited as required per signed confidentiality agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erkut Borazanci, MD principal investigator
HonorHealth Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paricalcitol (Zemplar) in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by HonorHealth Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response (BOR) (time frame: From enrollment until the end of 3+ treatment cycles (each cycle is 21 days), up to 190 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.