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

• Status: Active, not recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Azacitidine; Cc-486

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