Know Cancer

or
forgot password

A Phase 1, Open-Label, Dose-Ranging Study To Evaluate The Pharmacokinetics and Safety of Azacitidine Administered Subcutaneously and as Different Oral Formulations In Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML), Lymphoma, and Multiple Myeloma(MM)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Leukemia, Myelomonocytic, Chronic

Thank you

Trial Information

A Phase 1, Open-Label, Dose-Ranging Study To Evaluate The Pharmacokinetics and Safety of Azacitidine Administered Subcutaneously and as Different Oral Formulations In Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML), Lymphoma, and Multiple Myeloma(MM)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the dose for a given oral formulation that would yield similar exposure [area under the curve (AUC)] to 75 mg/m2 of the subcutaneous formulation.

Outcome Time Frame:

1 - 18 months

Safety Issue:

No

Principal Investigator

Barry Skikne, MD, FACP, FCP (SA)

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

AZA PH US 2008 CL008

NCT ID:

NCT00761722

Start Date:

September 2008

Completion Date:

December 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Lymphoma
  • Multiple Myeloma
  • Leukemia, Myelomonocytic, Chronic
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Lymphoma
  • Multiple Myeloma
  • Chronic Myelomonocytic Leukemia (CMML)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Chronic
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Northwest Cancer SpecialistsVancouver, Washington  98664
North Star Lodge Cancer CenterYakima, Washington  98902
Kansas University Medical CenterKansas City,, Kansas  66160-7390
Cancer Care Center of South TexasSan Antonio, Texas  78229