Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, PK & PD of Oral Azacitidine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (AML)
18 Years
N/A
Both
Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML)
Trial Information
Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, PK & PD of Oral Azacitidine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (AML)
Optional Extension Phase (OEP) to the AZA PH US 2007 CL 005 study which allows subjects who
continue to receive oral azaitidine and have stable disease or are demonstrating clinical
benefit as assessed by the Investigator, and have consented to participate, may enter the
OEP of this study (at their current doses) at the start of their next cycle.
Subjects who are entering the OEP should be discontinued from Part 1 or Part 2 protocol
prescribed therapy in the AZA PH US 2007 CL 005 study.
Subjects may continue to receive oral azacitidine in the OEP until they meet the criteria
for study discontinuation or oral azacitidine becomes commercially available. Subjects
discontinuing from the OEP will have an OEP discontinuation visit 28 days after the last
dose of study drug or at study withdrawal.
Primary Objective of OEP is to evaluate long term safety of oral azacitidine.
Inclusion Criteria:
- 18 years or older.
- Diagnosis of low or Int-1 risk MDS
- Low platelet count, and/or low hemoglobin, and/or RBC transfusion-dependent and/or
platelet transfusion-dependent
- ECOG Performance status 0-2
- Standard safety inclusion for serum creatinine, AST, ALT, bilirubin.
- Serum bicarbonate greater than or equal to 20 mEq/L.
- Use of acceptable birth control.
- Signed, written informed consent.
Exclusion Criteria:
- Diagnosis of acute PML.
- Previous or concurrent malignancy.
- Prior treatment with azacitidine or other demethylating agents.
- Treatment with any anticancer therapy or investigational drugs within 21 days.
- Hypersensitivity to azacitidine or mannitol.
- Presence of GI disease.
- Active, uncontrolled infection.
- Known Human Immunodeficiency Virus (HIV) or Hepatitis C, or known active viral
Hepatitis B.
- Breastfeeding or Pregnant females;
- Presence of serious illness, medical condition, or other medical history which would
be likely to interfere with a subject's participation in the study or with the
interpretation of the results.
- Current congestive heart failure (NY Heart Association Class III-IV), unstable angina
or angina requiring surgical or medical intervention within 6 months, myocardial
infarct within 6 months, or uncontrolled cardiac arrhythmia.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety evaluation as measured by monitoring AEs, dose limiting toxicities, scheduled lab assessments, vital sign measurements, ECGs, & physical exams for study duration. Adverse changes in physical signs/symptoms will be graded according to CTC AE V.3.0.
Outcome Time Frame:
60 months
Safety Issue:
Yes
Principal Investigator
Barry Skikne, M.D., FACP; FCP (SA)
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
United States: Food and Drug Administration
Study ID:
AZA PH US 2007 CL005
NCT ID:
NCT00528983
Start Date:
September 2007
Completion Date:
June 2014
Related Keywords:
- Myelodysplastic Syndromes (MDS)
- Chronic Myelomonocytic Leukemia (CMML)
- Acute Myelogenous Leukemia (AML)
- Myelodysplastic Syndromes MDS
- Acute Myelogenous Leukemia AML
- Chronic Myelomonocytic Leukemia CMML
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myelomonocytic, Chronic
- Myelodysplastic Syndromes
- Preleukemia
- Leukemia, Myelomonocytic, Acute
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Virginia Oncology Associates | Newport News, Virginia 23606 |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Shands Cancer Center at the University of Florida | Gainesville, Florida 32610-0342 |
| North Star Lodge Cancer Center | Yakima, Washington 98902 |
| University of Chicago | Chicago, Illinois 60637 |
| Kansas University Medical Center | Kansas City,, Kansas 66160-7390 |
| Texas Oncology Cancer Center | Austin, Texas 78731 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Kansas City VA Medical Center | Kansas City, Missouri 64128 |
| New York Oncology Hematology P.C. | Albany, New York 12208 |
| Institute of Translational Oncology Research | Greenville, South Carolina 29605 |
| Gabrail Cancer Center Reearch | Canton, Ohio 44718 |
| MD Anderson - University of Texas | Houston, Texas 77030 |
| Cancer Centers of South Texas - HOAST | San Antonio, Texas 78229 |
