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



Status:Recruiting
Conditions:Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/24/2018
Start Date:October 22, 2015
End Date:December 31, 2020
Contact:Associate Director Clinical Trial Disclosure
Email:clinicaltrialdisclosure@celgene.com
Phone:1-888-260-1599

Use our guide to learn which trials are right for you!

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

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

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.

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
We found this trial at
4
sites
5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Baltimore, Maryland 21231
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
3450 Hull Road
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials