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A Study to Evaluate Long-term Safety in Subjects With Solid Tumors and Hematological Disorders.

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ClinicalTrials.gov Identifier: NCT02494258
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
Rollover study supporting solid tumor and hematological disorder indications from Celgene sponsored CC-486 protocols eligible for participation in the study.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasm Neoplasms Drug: CC-486 Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:
The open-label, multicenter, multinational rollover study is intended to evaluate the safety of CC-486, while providing continued treatment with CC-486 for subjects who are receiving single agent CC-486 at the time of transition to the rollover study and tolerated the protocol prescribed regimen in Celgene-sponsored trials, and whom in the opinion of the Investigator may derive clinical benefit from continuing treatment with CC-486. Subjects' survival will also be followed if required by the parent CC-486 study protocol. If approved by Celgene, subjects from any ongoing or future Celgene sponsored CC-486 studies in solid tumors and hematological disorders will be included in this protocol.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Single-Arm Rollover Study to Evaluate Long-Term Safety in Subjects Who Participated in Other Celgene Sponsored CC-486 (Oral Azacitidine) Clinical Trials in Solid Tumors and Hematological Disorders
Actual Study Start Date : October 22, 2015
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders
Drug Information available for: Azacitidine

Arm Intervention/treatment
Experimental: Oral Azacitidine (CC-486)
This study is an open-label, single-arm study and is divided into the screening period, treatment period and follow-up period. It is intended to evaluate the long-term safety of CC-486 and is to be taken at the same dose, schedule and frequency used from the last dose of CC-486 given in the parent study.
Drug: CC-486
The subject will continue at the same dose, frequency and schedule used for the last dose of CC-486 given in the preceding CC-486 study. Subjects are allowed to rollover after the last cycle is finished and before the new cycle begins in the parent protocol. There is a 7 day window from End of Study on the parent protocol and when the participant will start Day 1 of the rollover study.
Other Name: Oral Azacitidine




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Approximately 5 years ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health including laboratory test values, regardless of etiology.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 5 years ]
    Time from randomization until death from any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously participated in, and received oral azacitidine, and continues to fulfill the eligibility criteria in one of the parent oral azacitidine clinical trials.

    The Investigator believes the subject is tolerating treatment with oral azacitidine monotherapy and continued oral azacitidine treatment is of benefit to the subject.

  2. Understand and voluntarily sign an informed consent document prior to any study related assessments or procedures being conducted.
  3. Willing and able to adhere to the study visit schedule and other protocol requirements.
  4. Females of childbearing potential (FCBP) may participate, provided they meet the following conditions:

    1. Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
    2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting investigational product, during the study therapy (including dose interruptions), and for 3 months, or longer if required by local regulations, after discontinuation of study therapy.
  5. Male subjects must:

    1. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 3 months, or longer if required by local regulations, following Investigational Product (IP) discontinuation, even if he has undergone a successful vasectomy.

Subjects must satisfy the following criteria to participate in the Survival Follow-up phase:

  1. In order to be enrolled for the survival follow-up in the Follow-up Phase of the rollover study, subjects must have been in a parent oral azacitidine study where monitoring for survival was required and have signed informed consent for follow-up phase.
  2. Understand and voluntarily sign an informed consent document for this study.
  3. Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

The presence of any of the following will exclude a subject from receiving investigational product in the study:

  1. Concomitant use of drugs that are prohibited.
  2. Prior chemotherapy (including injectable azacitidine) or radiotherapy or any investigational agent after the last dose of oral azacitidine administered as part of the parent oral azacitidine study.
  3. Subjects have met one or more criteria for discontinuation as stipulated in the parent oral azacitidine study.
  4. Subjects received oral azacitidine in combination with another compound during a parent oral azacitidine study (Subjects form multi-arm parent oral azacitidine studies will be allowed to enroll into the rollover study, if the subject is receiving single-agent oral azacitidine at the time of transition into the rollover study).
  5. A subject's transition into rollover study ≥ 45 days after End of the Study visit of the parent oral azacitidine study
  6. Pregnant or lactating females. There are no exclusion criteria to prevent entry or remaining on the follow-up phase of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494258


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
United States, Florida
University of Florida College of Med Recruiting
Gainesville, Florida, United States, 32610-0277
United States, Maryland
Johns Hopkins Oncology Center Recruiting
Baltimore, Maryland, United States, 21231
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Virginia Oncology Associates Not yet recruiting
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Celgene
Investigators
Study Director: Barry Skikne, MD, FACP; FCP Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02494258     History of Changes
Other Study ID Numbers: CC-486-GEN-001
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Keywords provided by Celgene:
CC-486
Oral Azacitidine
Solid tumors
hematological disorders
rollover study

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Hematologic Diseases
Neoplasms by Site
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors