Breast Cancer Clinical Trial
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
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.
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.
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