Last updated on September 2017

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


Brief description of study

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.

Detailed Study Description

Stage I - Pharmacokinetics (Bioequivalence) Subjects will be randomized to receive CC-486 300 mg orally on each of the two pharmacokinetic (PK) study days based on the dosing sequences they are randomized to: Dosing Sequence 1: 2x150 mg tablets followed by 1x30 mg tablet. Dosing Sequence 2: 1x300 mg tablet followed by 2x150 mg tablets. Each dose will be administered in the clinic at least 48 hours apart between PK dosing day 1 and PK dosing day 2 over a period no longer than 10 days under fasted conditions. Stage II - Pharmacokinetics (Food Effect) Subjects will be randomized to receive CC-486 300 mg orally on each of the two PK study days based on the dosing sequences they are randomized to: Dosing Sequence 1: 1x300 mg tablet under fasted condition followed by 1x300 mg tablet under fed condition. Dosing Sequence 2: 1x300 mg tablet under fed condition followed by 1x300 mg tablet under fasted condition. Each dose will be administered in the clinic at least 48 hours apart between PK dosing day 1 and PK dosing day 2 over a period no longer than 10 days. The sponsor will generate the randomization scheme and assign subjects upon enrollment to the appropriate sequence for dosing: Fasted condition: following an overnight fast of at least 10 hours, subjects will ingest oral Azacitidine with 240 mL of room temperature water. Subjects must fast for a minimum of 4 hours following oral Azacitidine administration. Subjects may drink water as desired, except for 1 hour before and 1 hour after oral Azacitidine administration. Fed condition: following an overnight fast of at least 10 hours and following the performance of all required pre-dose assessments, subjects randomized to receive test medication in a fed state will begin ingesting a breakfast meal 30 (±5) minutes prior to the planned administration of oral Azacitidine. They will continue the entire meal within 20 to 25 minutes (no less than 20 minutes) from the time the meal is served. Subjects will then ingest oral Azacitidine with 240 mL of room temperature water. Subjects must fast a minimum of 4 hours following oral Azacitidine administration. Subjects may drink water as desired, except for 1 hour before and 1 hour after administration of oral Azacitidine. Extension Phase (for subjects who have completed PK Stage I or Stage II) Subjects continuing beyond the pharmacokinetics phase (Stage I or Stage II) will enter the extension phase of the study at the discretion of the investigator to receive < 6 (four-week) cycles of Vidaza 75 mg/m2 IV or SC daily for 7 days in the clinic and repeat every 4 weeks per prescribed label at the discretion of the investigator for ≤ 6 (four-week) cycles.

Clinical Study Identifier: NCT02223052

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Michael Pinho

Scottsdale Healthcare Research Institute
Scottsdale, AZ United States
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Michael Pinho

Mayo Clinic - Arizona
Scottsdale, AZ United States
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Michael Pinho

University of Arizona Cancer Center
Tucson, AZ United States
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Michael Pinho

University of Iowa
Iowa City, IA United States
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Michael Pinho

Henry Ford Health System
Detroit, MI United States
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Michael Pinho

Veteran Affairs Medical Center, Research #517
Kansas City, MO United States
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Michael Pinho

Cancer Institute of New Jersey
New Brunswick, NJ United States
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Michael Pinho

Cleveland Clinic Foundation
Cleveland, OH United States
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Michael Pinho

Greenville Hospital System
Greenville, SC United States
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Michael Pinho

Vanderbilt- Ingram Cancer Center
Nashville, TN United States
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Michael Pinho

The Methodist Hospital Research Institute l
Houston, TX United States
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