CC-486 (Oral Azacitidine) Bioequivalence Study in Patients With Solid Tumor or Hematologic Malignancies | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02223052

CC-486 (Oral Azacitidine) Bioequivalence Study in Patients With Solid Tumor or Hematologic Malignancies
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This is a Phase 1, open-label, multicenter, randomized, 2-period crossover study consisting of 2 phases: Pharmacokinetics and Extension.

The study will enroll approximately 60 subjects with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver. Approximately 8 sites in the US will participate in this study.

Status: 
Recruiting
Study Date: 
Wed, 10/01/2014 to Thu, 06/02/2016
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: CC-486 Arm 1: Two 150-mg tablets of CC-486 on Day 1 and 1 x 300 mg CC-486 on Day 2 Arm 2: 1 x 300mg tablet of CC 486 on Day 1 and 2 x 150mg CC-486 on Day 2 Other Name: Oral Azacitdine Drug: Vidaza 75mg/m^2 IV or SC daily x 7 days every 4 weeks for ≤ 6 (four-week) cycles Other Names: Azacitidine for Injection AZA