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A Randomised, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Finding Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia, Cancer

Thank you

Trial Information

A Randomised, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Finding Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy


Inclusion Criteria:

Part A: - Non-myeloid malignancy receiving multicycle chemotherapy -
Receiving non-platinum containing chemotherapy - At least 6 additional weeks of cyclic
cytotoxic chemotherapy planned Part B and Part C: - Non-myeloid malignancy receiving
multicycle chemotherapy - At least 12 additional weeks of cyclic cytotoxic chemotherapy
planned All Parts: - Chemotherapy induced anemia - Greater than 6 month life expectancy -
ECOG 0-2 - Adequate renal and liver function Exclusion Criteria: - Chronic myeloid
leukemia, AML, ALL, Burkitt's lymphoma or lymphoblastic lymphoma - History of seizure
disorder - Primary hematologic disorder which could cause anemia, other than a non-myeloid
malignancy - Unstable angina, congestive heart failure or uncontrolled cardiac arrhythmia
- Uncontrolled hypertension - History of pure red cell aplasia - Clinically significant
inflammatory disease or active infection - Iron deficiency - ANC less than 0.8 x 10^9
cells/L

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Incidence and severity of adverse events

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Human Research Ethics Committee

Study ID:

20030205

NCT ID:

NCT00119600

Start Date:

Completion Date:

Related Keywords:

  • Anemia
  • Cancer
  • Non-myeloid malignancy
  • Clinical Trial
  • Anemia
  • Neoplasms

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