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A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Leukemias and Related Disorders


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer, Hematologic Malignancies, Leukemia, Myeloid Leukemia

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Trial Information

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Leukemias and Related Disorders


Inclusion Criteria:



- Men or women ≥ 18 years old

- Part 1 - Dose Escalation only: Pathologically documented, definitively diagnosed,
leukemia or related disorder that has failed standard treatment, for which no
standard therapy is available. Patients with myelodysplasia (MDS), chronic
myelomonocytic leukemia (CMML), acute myeloid leukemia (AML), acute lymphocytic
leukemia (ALL), and chronic myelogenous leukemia (CML) are eligible for Part 1 of
this study Part 2 - Dose Expansion only: Pathologically documented, definitively
diagnosed, acute myeloid leukemia that has failed standard treatment, for which no
standard therapy is available.

- Must consent to undergo bone marrow biopsies per schedule of assessments

Exclusion Criteria:

- White blood cell greater than 20,000 uL

- History of or active central nervous system leukemia

- Prior allogeneic bone marrow transplant

- Subject will not be available for protocol-required study visits or procedures

Other Inclusion/ Exclusion Criteria may apply to qualify for enrollment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Subject incidence of adverse events

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20101351

NCT ID:

NCT01380756

Start Date:

July 2011

Completion Date:

July 2014

Related Keywords:

  • Cancer
  • Hematologic Malignancies
  • Leukemia
  • Myeloid Leukemia
  • Amgen
  • Phase 1
  • Clinical Trial
  • Aurora kinase inhibitor
  • Open label
  • Oncology
  • Hematology
  • Neoplasms
  • Leukemia
  • Leukemia, Myeloid
  • Hematologic Neoplasms

Name

Location

Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteAbilene, Texas