AzTrials
AzTrials

Pancreatic CancerPhase 2NCT01845805

Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine)

A Phase 2 study testing oral azacitidine and Observation in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To improve progression free survival in high risk patients with resected pancreatic adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of adjuvant therapy. 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?
oral azacitidine and Observation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
4 sitesUnited States
Study dates
10 Jan 2014to 9 Apr 2021
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

  • Understand and voluntarily sign an informed consent form.
  • Age greater than or 18 years at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Subjects must have a histologically confirmed pancreatic adenocarcinoma that has had an R0 (negative margins) or R1 (microscopically positive margins) resection.
  • Subjects must have finished adjuvant therapy, which can include chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy. Although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy ± radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria.
  • Subjects enrolled due to node + disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy. Patients enrolling due to CA 19-9 elevations can enroll any time after adjuvant therapy has completed.
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  • All previous cancer therapy including radiation, chemotherapy, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
  • Subjects must either have a CA 19-9 value > the institutional ULN on two separate checks at least 2 weeks apart OR have had an R1 resection margin OR N1 nodal disease regardless of CA 19-9 level
  • Subjects must be free of visible disease on imaging (CT, PETCT or MRI) evaluating chest, abdomen, and pelvis within 28 days of enrollment on the study.
  • Life expectancy of greater than 12 weeks
  • ECOG performance status of less than or equal to 1 at study entry
  • Subjects must have normal organ and marrow function
  • Free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
  • Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with CC-486 or nab-paclitaxel. All men and women of childbearing potential must use effective methods of birth control throughout the study and for three months after completing treatment.
  • Women of childbearing potential must have a negative serum or urine β-hCG pregnancy test at screening.
  • Subjects must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or breastfeeding women.
  • Use of any other chemotherapy, radiotherapy, or experimental drug or therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment on study or those who have not recovered from adverse events ≥ grade 1 due to agents administered more than 4 weeks earlier except for stable grade 2 neuropathy.
  • Subjects may not receive any other concomitant investigational agents.
  • Known or suspected hypersensitivity to 5-azacitidine or mannitol
  • Known positive for HIV or infectious hepatitis, type B or C. HIV patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any known gastrointestinal disorders which would preclude oral administration of 5-azacitidine.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Johns Hopkins

    Baltimore, Maryland, 21205

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

Other trials in United States

About this study

Official title: A Phase II Trial to Improve Outcomes in Patients With Resected Pancreatic Adenocarcinoma at High Risk for Recurrence Using Epigenetic Therapy

To improve progression free survival in high risk patients with resected pancreatic adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of adjuvant therapy.

Read the detailed description

This trial is for patients with resected pancreatic adenocarcinoma who have concluded adjuvant therapy or were deemed unable to receive adjuvant therapy with an elevated CA19-9 or node positive or margin positive disease. CA 19-9 elevation is defined as two levels > the institutional upper limit of normal (ULN) taken at least 2 weeks apart. These levels should be measured after adjuvant therapy has concluded or upon the decision that adjuvant therapy will not be offered. Patients will be randomized to one of two arms. Subjects enrolled due to node positive disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy. Patients enrolling due to CA19-9 elevation can enroll any time after adjuvant therapy has completed. Arm A, the treatment arm, will be started on CC-486. Arm B, the control arm, will receive no additional therapy. In both arms, CA19-9 will be followed and CT scans (or MRI, if clinically indicated) will be done every three months. When patients have visible disease recurrence on imaging, CC-486 will be stopped and both groups will start first-line chemotherapy.

Being tested
oral azacitidine, Observation
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral azacitidineDrug

    Also called CC-486

  • ObservationOther

Study groups in NCT01845805
Study groupRoleWhat they receive
Arm A: CC-486ExperimentalCC-486 (oral azacitidine), 300 mg total, taken daily on days 1-21 (of a 28 day cycle) for up to 12 cycles. Upon disease recurrence, subjects will start on a first-line chemotherapy.
Receives: Drug: oral azacitidine
Arm B: observationActive comparatorObservation until disease recurrence. Upon disease recurrence, subjects will start on a first-line chemotherapy.
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    Progression free survival is defined as the time from randomization until visible recurrence on any imaging modality, a confirmed biopsy, or death. Individuals lost to follow-up prior to having an event will be censored at the time of the last scan or biopsy.

    Measured: 25 months

Secondary outcomes (2)

  1. Response Rate as Assessed by Number of Participants With Partial or Complete Response

    Response rate (partial response or complete response) to first-line chemotherapy when given after visible disease recurrence in patients primed with CC-486 compared to observation. Partial and complete responses were assessed by standard of care radiology reads and documented scan interpretations.

    Measured: 11 months

  2. Overall Survival

    Overall survival is defined as the time from randomization until death. Individuals lost to follow-up prior to death will be censored at the time of last physician contact.

    Measured: 47 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2013 (estimated)
  2. Study start10 Jan 2014
  3. Primary completion9 Apr 2021
  4. Study completion9 Apr 2021

Resources

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
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01845805
Sponsor's protocol ID
J12138
Other IDs
NA_00076474
Status last verified
Jun 2022
First submitted
16 Apr 2013
Last updated
4 Oct 2022
Data monitoring committee
Yes

Publications

  • Tost J, Ak-Aksoy S, Campa D, Corradi C, Farinella R, Ibanez-Costa A, Dubrot J, Earl J, Melian EB, Kataki A, Kolnikova G, Madjarov G, Chaushevska M, Strnadel J, Tanic M, Tomas M, Dubovan P, Urbanova M, Buocikova V, Smolkova B. Leveraging epigenetic alterations in pancreatic ductal adenocarcinoma for clinical applications. Semin Cancer Biol. 2025 Feb;109:101-124. doi: 10.1016/j.semcancer.2025.01.003. Epub 2025 Jan 23.

    PubMed 39863139

  • Heumann TR, Baretti M, Sugar EA, Durham JN, Linden S, Lopez-Vidal TY, Leatherman J, Cope L, Sharma A, Weekes CD, O'Dwyer PJ, Reiss KA, Monga DK, Ahuja N, Azad NS. A randomized, phase II trial of oral azacitidine (CC-486) in patients with resected pancreatic adenocarcinoma at high risk for recurrence. Clin Epigenetics. 2022 Dec 3;14(1):166. doi: 10.1186/s13148-022-01367-8.

    PubMed 36463226

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oral azacitidine and Observation in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 sites 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 16 inclusion and 8 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 22 Jul 2022). 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?

Progression-free Survival (time frame: 25 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01845805, which also lists 2 linked publications.

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 4 Oct 2022.

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