Pancreatic CancerPhase 2ViPNCT01601808
Clinical Trial Comparing Gemcitabine and Vandetanib Therapy With Gemcitabine Alone in Pancreatic Carcinoma
A Phase 2 study testing Caprelsa (vandetanib) in people with Pancreatic Cancer, run by University of Liverpool at 14 sites in United Kingdom.
Trial summary
ViP is a double blinded clinical trial which will compare gemcitabine and vandetanib chemotherapy with gemcitabine alone in patients with locally advanced or metastatic pancreatic carcinoma. 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?
- Caprelsa (vandetanib)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 10 Oct 2011to 5 Sep 2018
- 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
- Age ≥ 18 years.
- Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas.
- Locally advanced or metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radiation. Patients who have relapsed following previously resected Pancreatic Cancer can be included.
- Contrast enhanced computerised tomography (CT) scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment.
- Unidimensionally measurable disease as shown by CT scan, in accordance with RECIST guidelines (version 1.1)
- ECOG performance status 0, 1 or 2 where the investigator feels that treatment with combination chemotherapy.
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- Platelets ≥100 x 109/l; WBC ≥ 3 x 109/l; neutrophils ≥ 1.5 x 109/l at entry.
- Documented Life expectancy > 3 months.
- Informed written consent
Who cannot join
- Laboratory results:
- Serum bilirubin ≥ 1.5x the upper limit of reference range (ULRR).
- Haemoglobin < 10G/dl
- Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula)**. Patients with a creatinine clearance of ≥30mL/minute and <50mL/minute should begin vandetanib on a reduced dose of 200mg.
- Potassium, ≤4.0 mmol/L despite supplementation; or > 5.5 mmol/L
- Magnesium below the normal range despite supplementation, or > 1.23 mmol/L
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- Serum calcium is > 2.9 mmol/L. In cases where serum calcium is below the normal range this can be substituted with the value for calcium adjusted for albumin, if this is below the normal range despite supplementation patients should be excluded.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase (ALP) >2.5 x ULRR or > 5x ULRR if judged by the investigator to be related to liver metastases.
- Medical or psychiatric conditions compromising informed consent.
- Intracerebral metastases or meningeal carcinomatosis.
- Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
- Evidence of severe or uncontrolled systemic disease or any concurrent condition
- Clinically significant cardiovascular eventclassification of heart disease ≥2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
- History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
- QTc prolongation with other medications that required discontinuation of that medication.
- Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
- Presence of left bundle branch block (LBBB).
- QTc with Bazett's correction that is un-measurable or ≥ 480 msec on screening ECG. Patients who are receiving a drug that has a risk of inducing Torsades-de-Pointes are excluded if QTc is ≥ 460 msec.
- Any concurrent medication with a known risk of inducing Torsades-de-Pointes, that in the investigator's opinion cannot be discontinued, are allowed.
- Concomitant medications that are potent inducers.
- Hypertension not controlled by medical therapy.
- Currently active diarrhoea.
- Malabsorption syndrome.
- Pregnancy or breast feeding.
- Previous chemotherapy for locally advanced and metastatic disease. Adjuvant chemotherapy for resected pancreatic cancer will be permitted provided that chemotherapy was completed > 12 months previously.
- Radiotherapy within the last 4 weeks prior to start of study treatment.
- Concurrent malignancies or invasive cancers diagnosed within past 5 years.
- Chemotherapy directed at tumour apart from that described in this protocol.
- All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Belfast City Hospital
Belfast, BT9 7AB
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Royal Surrey County Hospital
Guildford, GU2 7XX
Clatterbridge Centre for Oncology
Liverpool, CH63 4JY
Royal Liverpool University Hospital
Liverpool, L69 3GA
St Bartholomew's Hospital
London, EC1A 7BE
Guys & St Thomas Hospital
London, SE1 9RT
Royal Marsden Hospital
London, SW3 6JJ
The Christie Hospital
Manchester, M20 4BX
James Cook University Hospital
Middlesbrough, TS4 3BW
Freeman Hospital
Newcastle, NE7 7DN
Nottingham City Hospital
Nottingham, NG5 1PB
Weston Park Hospital
Sheffield, S10 2SJ
About this study
Official title: A Prospective, Phase II, Double Blinded, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Vandetanib Therapy With Gemcitabine Therapy Alone in Locally Advanced or Metastatic Pancreatic Carcinoma
ViP is a double blinded clinical trial which will compare gemcitabine and vandetanib chemotherapy with gemcitabine alone in patients with locally advanced or metastatic pancreatic carcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- Placebo, Caprelsa (vandetanib)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Orally once a day, continuously throughout the study
Caprelsa (vandetanib)Drug
Orally once a daily, continuously throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine and Placebo | Placebo comparator | Standard therapeutic arm. Placebo orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles. Receives: Drug: Placebo |
| Gemcitabine and vandetanib | Experimental | Experimental arm. Vandetanib orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles. Receives: Drug: Caprelsa (vandetanib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To assess whether survival times for patients receiving gemcitabine plus vandetanib are longer than for those patients receiving gemcitabine alone as first line treatment for advanced pancreatic cancer
Measured: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Secondary outcomes (5)
Progression-free survival time
Measured: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Objective response rate
Measured: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Disease control rate
Measured: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Number and types of adverse events
Measured: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Patient pain assessment
Measured: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study start10 Oct 2011
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Dr Gary Middleton, Principal investigator, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601808
- Sponsor's protocol ID
- 2010-021951-26
- Other IDs
- 74555382
- Acronym
- ViP
- Status last verified
- May 2012
- First submitted
- 22 Feb 2012
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II, Double Blinded, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Vandetanib Therapy With Gemcitabine Therapy Alone in Locally Advanced or Metastatic Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT01601808
- Acronym / sponsor ID
- ViP / 2010-021951-26
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 10 Oct 2011 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 18 May 2012 (estimated)
- 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.
ViP is a double blinded clinical trial which will compare gemcitabine and vandetanib chemotherapy with gemcitabine alone in patients with locally advanced or metastatic pancreatic carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine and Placebo | Placebo comparator | Drug: PlaceboStandard therapeutic arm. Placebo orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles. |
| Gemcitabine and vandetanib | Experimental | Drug: Caprelsa (vandetanib)Experimental arm. Vandetanib orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas.
- Locally advanced or metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radiation. Patients who have relapsed following previously resected Pancreatic Cancer can be included.
- Contrast enhanced computerised tomography (CT) scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment.
- Unidimensionally measurable disease as shown by CT scan, in accordance with RECIST guidelines (version 1.1)
Key exclusion criteria (29 listed)
- Laboratory results:
- Medical or psychiatric conditions compromising informed consent.
- Intracerebral metastases or meningeal carcinomatosis.
- Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
- Evidence of severe or uncontrolled systemic disease or any concurrent condition
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 |
|---|---|---|
| PlaceboOrally once a day, continuously throughout the study | Drug | Gemcitabine and Placebo |
| Caprelsa (vandetanib)Orally once a daily, continuously throughout the study. | Drug | Gemcitabine and vandetanib |
Primary outcome
Overall survival
Time frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
To assess whether survival times for patients receiving gemcitabine plus vandetanib are longer than for those patients receiving gemcitabine alone as first line treatment for advanced pancreatic cancer
5 secondary outcomes
Progression-free survival time
Time frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Objective response rate
Time frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Disease control rate
Time frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Number and types of adverse events
Time frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Patient pain assessment
Time frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
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 13 Mar 2025.
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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.
Dr Gary Middleton principal investigator
Royal Surrey County Hospital NHS Foundation Trust
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caprelsa (vandetanib) in people with Pancreatic Cancer, run by University of Liverpool at 14 sites 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 9 inclusion and 29 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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. Some participants in this study may receive a placebo. 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?
Overall survival (time frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation). 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 13 Mar 2025.