Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00239239
First received: October 13, 2005
Last updated: March 4, 2010
Last verified: March 2010

October 13, 2005
March 4, 2010
August 2005
January 2007   (final data collection date for primary outcome measure)
To characterize the PK of darbepoetin alfa administered at a SC dose of 0.45 mcg/kg TIW in the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
To characterize the PK of darbepoetin alfa administered at a SC dose of 0.45 mcg/kg TIW in the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy
Complete list of historical versions of study NCT00239239 on ClinicalTrials.gov Archive Site
To assess the effect of darbepoetin alfa treatment on hematopoietic response, red blood cell (RBC) transfusion requirements, and the safety of darbepoetin alfa in subjects receiving multicycle chemotherapy [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
To assess the effect of darbepoetin alfa treatment on hematopoietic response, RBC transfusion requirements, and the safety of darbepoetin alfa in subjects receiving multicycle chemotherapy
Not Provided
Not Provided
 
Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies
An Open-label, Single-arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Darbepoetin Alfa Administered Three Times Per Week for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy

The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Myeloid Malignancies
  • Anemia
  • Cancer
Drug: Darbepoetin alfa
darbepoetin alfa SC dosing 0.45 mcg/kg 3 times per week through study day 40. Optional extended treatment period: 200 mcg Q2W through study day 110
Experimental: test treatment period
Intervention: Drug: Darbepoetin alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
March 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-myeloid malignancy
  • Currently receiving 3-week cyclic chemotherapy treatment with a minimum of 2 additional cycles of chemotherapy planned at the time of enrollment
  • Anemia predominately due to cancer or chemotherapy (Hb >= 9.0 and < 11.0 g/dL) at the time of screening
  • 18 years of age or older at the time of screening
  • Eastern Cooperative Oncology Group (ECOG) score 0-2
  • Adequate liver and kidney function Exclusion Criteria:
  • Known primary hematologic disorder, which could cause anemia, other than non-myeloid malignancies
  • History of chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), hairy cell leukemia, Burkitt's lymphoma, or lymphoblastic lymphoma
  • Serum folate <= 2.0 ng/mL or vitamin B12 <= 200 pg/mL at screening (anemia related to nutritional deficiencies)
  • Iron deficiency [transferrin saturation (TSAT) < 15% and serum ferritin < 10 ng/mL] at screening
  • Other diagnoses not related to cancer or chemotherapy, which cause anemia (ie, hemolysis, bleeding, sickle cell anemia)
  • Clinically significant inflammatory disease as determined by the investigator (eg, rheumatoid arthritis, Crohn's disease)
  • Clinically significant co-morbid medical or psychiatric conditions that may impact subject safety or confound the ability to evaluate study endpoint as determined by the investigator
  • Unstable or uncontrolled cardiac disease or condition (ie, angina, congestive heart failure, or cardiac arrhythmia)
  • Diastolic blood pressure > 100 mmHg at screening
  • Known hypersensitivity of erythropoietic-stimulating proteins (ESPs) or any excipients
  • Known history of pure red cell aplasia
  • Known positive antibody response to an ESP
  • Use of investigational agents not approved or any indication during the previous 30 days prior to enrollment
  • ESP therapy (i.e., recombinant human erythropoietin [rHuEPO] or darbepoetin alfa) within 21 days prior to screening or between screening and the first dose of study drug
  • RBC transfusion(s) within 21 days prior to screening
  • Pregnant or breast-feeding women - Previously enrolled in this study
  • Known to be HIV, hepatitis B or C positive
  • Any disorder that would compromise the ability of the subject to give written informed consent and comply with study requirements and procedures
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00239239
20040232
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
March 2010

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