Pancreatic AdenocarcinomaNCT02496832
A Study of Hypoxia Imaging in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine and TH-302 or TH-302 Placebo
A study testing 18F-Fluoroazomycin arabinoside in people with Pancreatic Adenocarcinoma and Advanced Disease, run by University Health Network, Toronto.
Trial summary
Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Advanced Disease, Metastatic Disease
- What is being tested?
- 18F-Fluoroazomycin arabinoside
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2014
- Phase
- Interventional
- 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
- Have consented to participating on the first-line Gemcitabine + TH-302/placebo (study number EMR200592-001) study
- Age 18 years or older
- Cytologic/histologic diagnosis of pancreatic adenocarcinoma
- Advanced stage pancreatic cancer: locally advanced or metastatic.
- No prior chemotherapy for advanced/metastatic disease. Adjuvant chemotherapy allowed if completed > 6mths from study entry. Prior radio-sensitizing doses of 5-FU or gemcitabine also allowed.
- ECOG performance status 1 or less
Show all 12Show fewer
- Adequate end organ and marrow function
- Measureable or non-measureable disease by RECIST 1.1
- Female patients of child-bearing potential must have a negative serum pregnancy test (BhCG) and must agree to abstinence or use adequate contraception for the duration of the study
- Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ (DCIS) breast disease).
- Ability to provide written informed consent
- Must be able to lie flat comfortably for 30 to 60 min to complete imaging study
Who cannot join
- Inability to lie supine for 30 to 60 minutes
- Concurrent second primary
- Life expectancy of less than 12 weeks
- On treatment with disulfiram (antabuse) due to [18F]FAZA injection containing up to 10% (v/v) ethanol in PBS (phosphate-buffered saline)
About this study
Official title: An Exploratory Study of Hypoxia Imaging Using 18F-FAZA-PET in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine + TH-302/Placebo (MAESTRO: EMR200592-001)
Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. This study will look at hypoxia in pancreatic tumours while participants are receiving treatment with the combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study.
This study will use positron emission tomography (PET) scans to look at hypoxia in tumours. PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to "label" areas of hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans and comparing these levels with the patient's response to treatment with gemcitabine and TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment.
The main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.
- Being tested
- 18F-Fluoroazomycin arabinoside
- Keywords
- Hypoxia, 18F-FAZA, 18F-Fluoroazomycin arabinoside, Positron emission tomography, PET, Participating in study EMR200592-001
- Medical subject headings
- Neoplasm Metastasis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluoroazomycin arabinosideDrug
Also called 18F-FAZA, [18F] FAZA
| Study group | Role | What they receive |
|---|---|---|
| FAZA PET-CT scan | Experimental | FAZA PET-CT imaging within 14 days of treatment from the EMR200592-001 study.
FAZA PET-CT imaging about 5 weeks after start of treatment from the EMR200592-001 study. Receives: Drug: 18F-Fluoroazomycin arabinoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expected number of similar quality scans produced compared to actual number of similar quality scans produced using the same method is less than 15%.
Measured: 2 years
Number of enrolled patients that complete all required scans compared to total number of patients enrolled in the study is at least 70%.
Measured: 2 years
Range of tumor hypoxia in patients with pancreatic cancer that had not received prior treatment.
Measured: 2 years
Secondary outcomes (3)
Compare the changes in tumor hypoxia before chemotherapy treatments and after chemotherapy treatments.
Measured: 2 years
Compare the changes in tumor hypoxia with response to chemotherapy treatments.
Measured: 2 years
Evaluate how FAZA is taken in by different tumor types within individual patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Study was never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Frosst Canada Ltd.
- Responsible party
- Sponsor
- Investigators
- Neesha Dhani, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496832
- Sponsor's protocol ID
- Faza-Maestro
- Status last verified
- Feb 2018
- First submitted
- 28 May 2014
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Hypoxia Imaging Using 18F-FAZA-PET in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine + TH-302/Placebo (MAESTRO: EMR200592-001)
- ClinicalTrials.gov ID
- NCT02496832
- Acronym / sponsor ID
- Faza-Maestro
- Keywords
- Hypoxia, 18F-FAZA, 18F-Fluoroazomycin arabinoside, Positron emission tomography, PET, Participating in study EMR200592-001
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Merck Frosst Canada Ltd.
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Jul 2015 (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.
Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. This study will look at hypoxia in pancreatic tumours while participants are receiving treatment with the combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study.
This study will use positron emission tomography (PET) scans to look at hypoxia in tumours. PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to "label" areas of hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans and comparing these levels with the patient's response to treatment with gemcitabine and TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment.
The main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAZA PET-CT scan | Experimental | Drug: 18F-Fluoroazomycin arabinosideFAZA PET-CT imaging within 14 days of treatment from the EMR200592-001 study. FAZA PET-CT imaging about 5 weeks after start of treatment from the EMR200592-001 study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have consented to participating on the first-line Gemcitabine + TH-302/placebo (study number EMR200592-001) study
- Age 18 years or older
- Cytologic/histologic diagnosis of pancreatic adenocarcinoma
- Advanced stage pancreatic cancer: locally advanced or metastatic.
- No prior chemotherapy for advanced/metastatic disease. Adjuvant chemotherapy allowed if completed > 6mths from study entry. Prior radio-sensitizing doses of 5-FU or gemcitabine also allowed.
Key exclusion criteria (4 listed)
- Inability to lie supine for 30 to 60 minutes
- Concurrent second primary
- Life expectancy of less than 12 weeks
- On treatment with disulfiram (antabuse) due to [18F]FAZA injection containing up to 10% (v/v) ethanol in PBS (phosphate-buffered saline)
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 |
|---|---|---|
| 18F-Fluoroazomycin arabinosideAlso: 18F-FAZA, [18F] FAZA | Drug | FAZA PET-CT scan |
Primary outcome
Expected number of similar quality scans produced compared to actual number of similar quality scans produced using the same method is less than 15%.
Time frame: 2 years
Number of enrolled patients that complete all required scans compared to total number of patients enrolled in the study is at least 70%.
Time frame: 2 years
Range of tumor hypoxia in patients with pancreatic cancer that had not received prior treatment.
Time frame: 2 years
3 secondary outcomes
Compare the changes in tumor hypoxia before chemotherapy treatments and after chemotherapy treatments.
Time frame: 2 years
Compare the changes in tumor hypoxia with response to chemotherapy treatments.
Time frame: 2 years
Evaluate how FAZA is taken in by different tumor types within individual patients.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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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.
Neesha Dhani, M.D. principal investigator
Princess Margaret Cancer Centre
Questions about this trial
What is this clinical trial studying?
A study testing 18F-Fluoroazomycin arabinoside in people with Pancreatic Adenocarcinoma and Advanced Disease, run by University Health Network, Toronto.
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 12 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Expected number of similar quality scans produced compared to actual number of similar quality scans produced using the same method is less than 15%. (time frame: 2 years). 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 19 Feb 2018.