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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00761722
First received: September 25, 2008
Last updated: January 14, 2014
Last verified: January 2014

September 25, 2008
January 14, 2014
September 2008
June 2014   (final data collection date for primary 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. [ Time Frame: 1 - 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00761722 on ClinicalTrials.gov Archive Site
  • To determine the oral bioavailability of up to 6 different oral formulations in comparison to the subcutaneous formulation [ Time Frame: 1 - 18 months ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of subcutaneous and oral formulations of azacitidine [ Time Frame: 1 - 18 months ] [ Designated as safety issue: Yes ]
  • To assess response rates [ Time Frame: 1 - 18 months ] [ Designated as safety issue: No ]
  • To assess RBC transfusion independence [ Time Frame: 1 - 18 months ] [ Designated as safety issue: No ]
  • To investigate the pharmacokinetics of oral azacitidine [ Time Frame: 1 -18 months ] [ Designated as safety issue: No ]
  • To assess the pharmacodynamic effects of oral azacitidine [ Time Frame: 1 -18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Lymphoma
  • Multiple Myeloma
  • Leukemia, Myelomonocytic, Chronic
Drug: azacitidine

Arm 1:

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.

Arm 2:

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

Other Name: Vidaza
  • Experimental: Arm 1

    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.

    Intervention: Drug: azacitidine
  • Experimental: Arm 2

    Oral Azacitidine

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

    Intervention: Drug: azacitidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
31
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00761722
AZA PH US 2008 CL008
No
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Barry Skikne, MD, FACP, FCP (SA) Celgene Corporation
Celgene Corporation
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP