A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00637052
First received: February 22, 2008
Last updated: September 19, 2012
Last verified: September 2012

February 22, 2008
September 19, 2012
February 2008
June 2010   (final data collection date for primary outcome measure)
  • Establish the maximum tolerated dose (MTD) of the study drug. [ Time Frame: Part 1 ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics (PK) of the study drug. [ Time Frame: Part 1 ] [ Designated as safety issue: No ]
  • Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: Yes ]
  • Assess the efficacy of the study drug in terms of incidence of complete remission (CR) and hematologic improvement (CRp). [ Time Frame: Part 3 ] [ Designated as safety issue: No ]
To evaluate the safety of ARRY-520, in terms of Adverse Events, Dose Limiting Toxicity, Clinical laboratory tests, Weight, ECG, and Physical examinations. [ Time Frame: Phase I/II ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00637052 on ClinicalTrials.gov Archive Site
  • Assess the efficacy of the study drug in terms of incidence of CR and CRp. [ Time Frame: Part 1 and Part 2 ] [ Designated as safety issue: No ]
  • Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations. [ Time Frame: Part 3 ] [ Designated as safety issue: Yes ]
  • To evaluate pharmacokinetic parameters, including serial drug levels and trough concentrations. [ Time Frame: Phase I ] [ Designated as safety issue: No ]
  • To evaluate pharmacodynamic parameters, including serum nucleosomes, WBC IHC, and basal cytokine levels. [ Time Frame: Phase I/II ] [ Designated as safety issue: No ]
  • To evaluate efficacy parameters, in terms of incidence of CR and CRp. [ Time Frame: Phase I/II ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
Not Provided

This is a 2-phase study during which patients with select myeloid leukemias or advanced myelodysplastic syndrome (MDS), who have failed, refused or are not eligible for standard treatment, will receive investigational study drug ARRY-520.

The study has 3 parts. The first phase of the study, Phase 1, has 2 parts. In the first part of Phase 1, patients with select myeloid leukemias or advanced MDS will receive increasing doses of study drug on different schedules in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients (per schedule) from the US will be enrolled in Part 1 (Completed). In the second part of Phase 1, patients with advanced MDS will receive the best dose of study drug and schedule determined from the first part of the study. Approximately 10 patients from the US will be enrolled in Part 2 (Completed).

In the third part of the study, Phase 2, patients with acute myeloid leukemia (AML) or advanced MDS will receive the best dose of study drug and schedule determined from the first part of the study and will be followed to see what side effects the study drug causes and to see what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced MDS
  • Acute Myeloid Leukemia
Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
Experimental: ARRY-520
Intervention: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Khoury HJ, Garcia-Manero G, Borthakur G, Kadia T, Foudray MC, Arellano M, Langston A, Bethelmie-Bryan B, Rush S, Litwiler K, Karan S, Simmons H, Marcus AI, Ptaszynski M, Kantarjian H. A phase 1 dose-escalation study of ARRY-520, a kinesin spindle protein inhibitor, in patients with advanced myeloid leukemias. Cancer. 2012 Jul 15;118(14):3556-64. doi: 10.1002/cncr.26664. Epub 2011 Dec 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2010
June 2010   (final data collection date for primary outcome measure)

Key Inclusion Criteria (Part 2):

  • Patients with either Intermediate-2 or High risk MDS or with AML (>20% bone marrow blasts) with stable low or normal white blood cell count (WBC). Patients should have failed one prior chemotherapy regimen which should have included a hypomethylating agent.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
  • Discontinuation of prior treatment at least 2 weeks prior to the start of the study.
  • Adequate hepatic and renal function.
  • Additional criteria exist.

Key Exclusion Criteria (Part 2):

  • Concurrent cytotoxic therapy, or biological, endocrine and immunological response modifiers.
  • Previous radiation to >25% of bone marrow.
  • Other active malignancies.
  • Known positive serology for the human immunodeficiency virus (HIV).
  • Central nervous system involvement as documented by spinal fluid cytology.
  • Active, uncontrolled infection.
  • Additional criteria exist
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00637052
ARRAY-520-211
Not Provided
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
September 2012

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