Pancreatic CancerPhase 2PINBALLNCT04054362
Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 2 study testing Paclitaxel protein bound, Cisplatin and Gemcitabine in people with Pancreatic Cancer, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Paclitaxel protein bound, Cisplatin and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Nov 2018to 8 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Willing and able to provide written informed consent.
- Ability to comply with the protocol.
- Aged ≥ 18 years; male or female.
- Histologically or cytologically confirmed metastatic (stage IV) pancreatic ductal adenocarcinoma.
- Karnofsky performance status ≥70.
- 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
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- 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
- Coagulation: INR and aPTT ≤1.5 x ULN.
- Biochemistry: serum creatinine < 1.5mg/dl, bilirubin < 1.5 x ULN; AST / ALT ≤ 2.5 x ULN (or ≤ 5 x ULN in the presence of liver metastasis) calculated creatinine clearance ≥ 50ml/min (as measured by Cockcroft \& Gault)
- Life expectancy ≥ 12 weeks.
- Women of childbearing potential must agree not to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or using effective contraception) for the duration of the study and for 1 month after last dose of study treatment. Women of child bearing potential must have a negative serum or urine pregnancy test within 14 days of Cycle 1 Day 1 (preferably as close to the study treatment day as possible). Both male and female patients of reproductive potential must agree to use effective contraception from 2 weeks before the start of study treatment and until 6 month (female participants) or 6 months (male participants) after completion of treatment (as per protocol section 6.10.5).
- Tumour sites amenable to repeated biopsies.
- Willingness to undergo paired tumour biopsies during the trial
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 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.
- 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.
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- History of HIV infection.
- Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or anti-fungals (see Section 6.10).
- History of symptomatic genitourinary stones (e.g. kidney stones) within 12months of Cycle 1 Day 1.
- Pre-existing, clinically significant peripheral neuropathy ≥ G2
- Hypersensitivity to the active study drug substance or to any of its excipients as listed in section 6 of the SmPC of each study drug.
- Patients with a history of pneumonitis
- Patients with a history of a hearing impairment
- Patients who have received any live vaccines within 4 weeks prior to trial registration
- Patient is on prohibited concurrent medication (see Section 6.10). In particular, vitamin D and calcium supplements must be stopped at the time of enrolment and for the duration of study treatment.
- Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of study treatment, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
- Female patients who are pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Barts Health NHS Trust
London, London, Greater, EC1M 6BQ
About this study
Official title: 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 Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
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.
Read the detailed description
Pancreatic cancer is the fourth-highest cancer killer worldwide with an overall 5 year survival of about 8%. The only potentially curative procedure, surgical excision, is feasible in a minority of patients, but even in these patients the majority (~80%) die within 5 years. This study aims to see if adding paricalcitol (a vitamin D analogue) to chemotherapy can slow down tumour growth in patients with previously untreated metastatic pancreatic cancer.
Studies have shown vitamin D can change the pancreatic tumour microenvironment from an immunologically suppressive (tumour growth promoting) to an immunologically hostile one, slowing down tumour growth in this way.
Patients with pancreatic cancer that has spread to other organs and who have adequate hepatic and renal function are eligible. Participants will receive chemotherapy (paclitaxel and gemcitabine, with or without cisplatin). On development of stable disease or disease progression, paricalcitol will be added to the chemotherapy regimen and participants will continue on this treatment until their cancer stops responding to treatment. After that participants will be followed up 3 monthly for the collection of disease status and survival data.
Participants will be asked to donate tumour and blood samples to allow the research team to look at the effects on the tumour biology.
- Conditions
- Pancreatic Cancer
- Being tested
- Paclitaxel protein bound, Cisplatin, Gemcitabine, Paricalcitol
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel protein boundDrug
paclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced
CisplatinDrug
paclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced
GemcitabineDrug
paclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced
ParicalcitolDrug
paclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced
| Study group | Role | What they receive |
|---|---|---|
| With Cisplatin | Experimental | Paclitaxel Protein bound, Cisplatin, and Gemcitabine until stable or progressive disease, at which point Paricalcitol will be introduced. Receives: Drug: Paclitaxel protein bound; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paricalcitol |
| Without Cisplatin | Experimental | Paclitaxel Protein bound and Gemcitabine until stable or progressive disease, at which point Paricalcitol will be introduced. Receives: Drug: Paclitaxel protein bound; Drug: Gemcitabine; Drug: Paricalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit
To determine the clinical benefit of adding paricalcitol to the regimens of either paclitaxel protein bound plus gemcitabine or paclitaxel protein bound plus cisplatin plus gemcitabine for patients with stable or progressive metastatic PDA.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start29 Nov 2018
- Primary completion8 Feb 2021
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054362
- Sponsor's protocol ID
- 012255
- Acronym
- PINBALL
- Status last verified
- Nov 2025
- First submitted
- 23 Apr 2019
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04054362
- Acronym / sponsor ID
- PINBALL / 012255
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreatic cancer is the fourth-highest cancer killer worldwide with an overall 5 year survival of about 8%. The only potentially curative procedure, surgical excision, is feasible in a minority of patients, but even in these patients the majority (~80%) die within 5 years. This study aims to see if adding paricalcitol (a vitamin D analogue) to chemotherapy can slow down tumour growth in patients with previously untreated metastatic pancreatic cancer.
Studies have shown vitamin D can change the pancreatic tumour microenvironment from an immunologically suppressive (tumour growth promoting) to an immunologically hostile one, slowing down tumour growth in this way.
Patients with pancreatic cancer that has spread to other organs and who have adequate hepatic and renal function are eligible. Participants will receive chemotherapy (paclitaxel and gemcitabine, with or without cisplatin). On development of stable disease or disease progression, paricalcitol will be added to the chemotherapy regimen and participants will continue on this treatment until their cancer stops responding to treatment. After that participants will be followed up 3 monthly for the collection of disease status and survival data.
Participants will be asked to donate tumour and blood samples to allow the research team to look at the effects on the tumour biology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Cisplatin | Experimental | Drug: Paclitaxel protein bound, Drug: Cisplatin, Drug: Gemcitabine, Drug: ParicalcitolPaclitaxel Protein bound, Cisplatin, and Gemcitabine until stable or progressive disease, at which point Paricalcitol will be introduced. |
| Without Cisplatin | Experimental | Drug: Paclitaxel protein bound, Drug: Gemcitabine, Drug: ParicalcitolPaclitaxel Protein bound and Gemcitabine until stable or progressive disease, at which point Paricalcitol will be introduced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to provide written informed consent.
- Ability to comply with the protocol.
- Aged ≥ 18 years; male or female.
- Histologically or cytologically confirmed metastatic (stage IV) pancreatic ductal adenocarcinoma.
- Karnofsky performance status ≥70.
Key exclusion criteria (17 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 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.
- 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.
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 |
|---|---|---|
| Paclitaxel protein boundpaclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced | Drug | With Cisplatin, Without Cisplatin |
| Cisplatinpaclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced | Drug | With Cisplatin |
| Gemcitabinepaclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced | Drug | With Cisplatin, Without Cisplatin |
| Paricalcitolpaclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced | Drug | With Cisplatin, Without Cisplatin |
Primary outcome
Clinical benefit
Time frame: 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.
To determine the clinical benefit of adding paricalcitol to the regimens of either paclitaxel protein bound plus gemcitabine or paclitaxel protein bound plus cisplatin plus gemcitabine for patients with stable or progressive metastatic PDA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Paclitaxel protein bound, Cisplatin and Gemcitabine in people with Pancreatic Cancer, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 14 inclusion and 17 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 21 Nov 2025. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical benefit (time frame: 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.). 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 21 Nov 2025.