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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML)

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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 ClinicRochester, Minnesota  55905
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Shands Cancer Center at the University of FloridaGainesville, Florida  32610-0342
North Star Lodge Cancer CenterYakima, Washington  98902
University of ChicagoChicago, Illinois  60637
Kansas University Medical CenterKansas City,, Kansas  66160-7390
Texas Oncology Cancer CenterAustin, Texas  78731
Sarah Cannon Research InstituteNashville, Tennessee  37203
Kansas City VA Medical CenterKansas City, Missouri  64128
New York Oncology Hematology P.C.Albany, New York  12208
Institute of Translational Oncology ResearchGreenville, South Carolina  29605
Gabrail Cancer Center ReearchCanton, Ohio  44718
MD Anderson - University of TexasHouston, Texas  77030
Cancer Centers of South Texas - HOASTSan Antonio, Texas  78229