Pancreatic CancerPhase 1NCT01167816
Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
A Phase 1 study testing Vidaza in people with Pancreatic Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells. 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?
- Vidaza
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2014
- Phase
- Phase 1
- 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
- Patient must have pathologically confirmed diagnosis of pancreatic adenocarcinoma
- Must have measurable disease as defined by RECIST. RECIST evaluation must have occurred within 4 weeks prior to study entry
- Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for pancreatic cancer
- Karnofsky performance status of greater than or equal to 70%
- Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1
- Women of child bearing age must have negative serum pregnancy test prior to treatment
Who cannot join
- Known central nervous system tumor involvement
- Evidence of other active malignancy requiring treatment
- Clinically significant heart disease
- Active serious systemic disease, including active bacterial or fungal infection
- Active viral hepatitis or symptomatic HIV infection. Positive serology alone is not exclusionary
- Prior surgery with curative intent for pancreatic cancer
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- Prior or current chemotherapy or radiation therapy for pancreatic cancer. Palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed
- Breast feeding, pregnant, or likely to become pregnant during the study
- known or suspected hypersensitivity to azacitidine or mannitol
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.
Read the detailed description
This is a Phase I single arm study designed for subjects with newly diagnosed, unresectable pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery with curative intent for pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Vidaza
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VidazaDrug
Also called Azacitibine
Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| azacitabine | Experimental | Not described Receives: Drug: Vidaza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine maximum tolerated dose
There will be 5 planned cohorts that will receive the escalating doses of azicitidine and gemcitabine. There will be at least 3 patients in each cohort
Measured: 28 days
Toxicity
To describe the toxicity associated with the use of this combination regimen
Measured: 28 days
Secondary outcomes (1)
Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells
Perform multivariable regression models to explore and assess associations among changes in DNA methylation in peripheral blood cells, chemo effect on tumor (stable disease or shrinkage based on scans) and changes in tumor markers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: The study was terminated as the Prinicipal Investigator left the site- all previous subjects enrolled are deceased
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.
- More trials run by University of OklahomaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Osama Qubaiah, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167816
- Sponsor's protocol ID
- VZ-PANC-PI-0244
- Status last verified
- May 2014
- First submitted
- 21 Jul 2010
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01167816
- Acronym / sponsor ID
- VZ-PANC-PI-0244
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated as the Prinicipal Investigator left the site- all previous subjects enrolled are deceased
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jul 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Jul 2010 (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.
The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.
Detailed description
This is a Phase I single arm study designed for subjects with newly diagnosed, unresectable pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery with curative intent for pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| azacitabine | Experimental | Drug: Vidaza |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must have pathologically confirmed diagnosis of pancreatic adenocarcinoma
- Must have measurable disease as defined by RECIST. RECIST evaluation must have occurred within 4 weeks prior to study entry
- Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for pancreatic cancer
- Karnofsky performance status of greater than or equal to 70%
- Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1
Key exclusion criteria (9 listed)
- Known central nervous system tumor involvement
- Evidence of other active malignancy requiring treatment
- Clinically significant heart disease
- Active serious systemic disease, including active bacterial or fungal infection
- Active viral hepatitis or symptomatic HIV infection. Positive serology alone is not exclusionary
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 |
|---|---|---|
| VidazaAlso: AzacitibineVidaza will be administered subq daily for 5 consecutive days each 28-day cycle | Drug | azacitabine |
Primary outcome
Determine maximum tolerated dose
Time frame: 28 days
There will be 5 planned cohorts that will receive the escalating doses of azicitidine and gemcitabine. There will be at least 3 patients in each cohort
Toxicity
Time frame: 28 days
To describe the toxicity associated with the use of this combination regimen
1 secondary outcome
Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells
Results and safety
The study was stopped early (reason given: The study was terminated as the Prinicipal Investigator left the site- all previous subjects enrolled are deceased). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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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.
Osama Qubaiah, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vidaza in people with Pancreatic Cancer, run by University of Oklahoma 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 May 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: The study was terminated as the Prinicipal Investigator left the site- all previous subjects enrolled are deceased). Results are not available in the source record.
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?
Determine maximum tolerated dose (time frame: 28 days). The study lists 2 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 20 May 2014.