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

NCT01845805 | Completed Phase 2 Results DMC

• 2 other identifiers: J12138NA_00076474
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (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.

  25 months

Secondary Outcomes (2)

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

  11 months

• Overall Survival

  47 months

Study Arms (2)

Arm A: CC-486

EXPERIMENTAL

CC-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.

Drug: oral azacitidine

Arm B: observation

ACTIVE COMPARATOR

Observation until disease recurrence. Upon disease recurrence, subjects will start on a first-line chemotherapy.

Other: Observation

Interventions

oral azacitidine DRUG

Also known as: CC-486

Arm A: CC-486

Observation OTHER

Arm B: observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (4)

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (1)

• 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.

  PMID: 36463226 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Azacitidine; cc-486; Observation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Methods; Investigative Techniques

Results Point of Contact

• Title: Nilofer Azad, MD
• Organization: Sidney Kimmel Cancer Center at Johns Hopkins

nazad2@jhmi.edu

410-614-9169

Study Officials

• Nilofer Azad, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: May 3, 2013
• Study Start: January 10, 2014
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: October 4, 2022
• Results First Posted: July 22, 2022

Record last verified: 2022-06

Locations

US (4)