A Study to Evaluate Long-term Safety in Subjects With Solid Tumors and Hematological Disorders.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02494258|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2015
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Neoplasm Neoplasms||Drug: CC-486||Phase 2|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||February 28, 2021|
|Estimated Study Completion Date :||March 31, 2021|
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.
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
- 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.
- Overall Survival [ Time Frame: Up to 5 years ]Time from randomization until death from any cause
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
|United States, Florida|
|University of Florida College of Med|
|Gainesville, Florida, United States, 32610-0277|
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Director:||Barry Skikne, MD, FACP; FCP||Celgene|