Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma (RACE)

Celgene

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma; Lymphoma; Leukemia, Myelomonocytic, Chronic; Myelodysplastic Syndromes; Acute Myeloid Leukemia

Treatments: Drug: azacitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761722

AZA PH US 2008 CL008

Details and patient eligibility

About

The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Diagnosis of MDS or CMML
• Diagnosis of AML, Multiple myeloma, Hodgkin's or Non-Hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
• ECOG Performance Status 0-2
• Use of acceptable birth control
• Standard safety inclusion for serum creatinine, AST, ALT, bilirubin
• Serum bicarbonate greater than or equal to 20 mEq/L
• Platelet count greater than or equal to 25,000/uL
• Hemoglobin greater than or equal to 500/uL
• Signed informed consent

Exclusion criteria

• Diagnosis of acute promyelocytic leukemia
• Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
• Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
• Hypersensitivity to azacitidine or mannitol
• Active, uncontrolled infection
• Presence of GI disease, malignant tumors or other conditions known to interfere with ADME
• Known or active HIV, viral hepatitis B or C
• Breastfeeding or pregnant females
• Current or uncontrolled cardiac disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 2 patient groups

Arm 1

Experimental group

Description:

subcutaneous and oral azacitidine Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19. Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle.

Treatment:

Drug: azacitidine

Arm 2

Experimental group

Description:

Oral Azacitidine All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle.

Treatment:

Drug: azacitidine