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Completed

NCT Number: NCT00761722

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Chronic Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

California Cancer Care Inc, Greenbrae, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azacitidine

Drug

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 names: Vidaza

Primary outcomes

  1. 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

Secondary outcomes

  1. To determine the oral bioavailability of up to 6 different oral formulations in comparison to the subcutaneous formulation

    Time frame: 1 - 18 months

  2. To assess the safety and tolerability of subcutaneous and oral formulations of azacitidine

    Time frame: 1 - 18 months

  3. To assess response rates

    Time frame: 1 - 18 months

  4. To assess RBC transfusion independence

    Time frame: 1 - 18 months

  5. To investigate the pharmacokinetics of oral azacitidine

    Time frame: 1 -18 months

  6. To assess the pharmacodynamic effects of oral azacitidine

    Time frame: 1 -18 months

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase I, Dose-Ranging Study to Evaluate the Pharmacokinetics and Safety of Azacitidine Administered Subcutaneously (SC) and as Different Oral Formulations in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML), Lymphoma, and Multiple Myeloma

Acronym: RACE

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2008
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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