Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

ClinicalTrials.gov ID: NCT02223052

Public ClinicalTrials.gov record NCT02223052. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 12:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Open-label, Multicenter, Randomized, 2-Period, Crossover Study to Evaluate the Bioequivalence and Food Effect Bioavailability of CC-486 (Oral Azacitidine) Tablets in Adult Cancer Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.

Study identification

NCT ID: NCT02223052
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Celgene; Industry
Enrollment: 89 participants

Conditions and interventions

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 26, 2014
Primary completion: Jun 10, 2018
Completion: Dec 17, 2018
Last update posted: May 11, 2020

2014 – 2018

United States locations

U.S. sites: 10
U.S. states: 8
U.S. cities: 9

Facility	City	State	ZIP	Site status
Scottsdale Healthcare Research Institute	Scottsdale	Arizona	85258	—
Mayo Clinic - Arizona	Scottsdale	Arizona	85259	—
University of Arizona Cancer Center	Tucson	Arizona	85724	—
University of Iowa	Iowa City	Iowa	52242	—
Henry Ford Health System	Detroit	Michigan	48202-268	—
Cancer Institute of New Jersey	New Brunswick	New Jersey	08903	—
Cleveland Clinic Foundation	Cleveland	Ohio	44195	—
Greenville Hospital System	Greenville	South Carolina	29605	—
Vanderbilt- Ingram Cancer Center	Nashville	Tennessee	37232-6307	—
The Methodist Hospital Research Institute l	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02223052, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 11, 2020 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02223052 live on ClinicalTrials.gov.

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