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

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ClinicalTrials.gov Identifier: NCT00637052
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 22, 2008
First Posted Date  ICMJE March 17, 2008
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE March 18, 2008
Actual Primary Completion Date June 21, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2011)
  • Establish the maximum tolerated dose (MTD) of the study drug. [ Time Frame: Part 1 ]
  • Characterize the pharmacokinetics (PK) of the study drug. [ Time Frame: Part 1 ]
  • 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 ]
  • Assess the efficacy of the study drug in terms of incidence of complete remission (CR) and hematologic improvement (CRp). [ Time Frame: Part 3 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2011)
  • Assess the efficacy of the study drug in terms of incidence of CR and CRp. [ Time Frame: Part 1 and Part 2 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2008)
  • To evaluate pharmacokinetic parameters, including serial drug levels and trough concentrations. [ Time Frame: Phase I ]
  • To evaluate pharmacodynamic parameters, including serum nucleosomes, WBC IHC, and basal cytokine levels. [ Time Frame: Phase I/II ]
  • To evaluate efficacy parameters, in terms of incidence of CR and CRp. [ Time Frame: Phase I/II ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
Official Title  ICMJE A Phase 1/2 Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced MDS
  • Acute Myeloid Leukemia
Intervention  ICMJE Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
Study Arms  ICMJE Experimental: ARRY-520
Intervention: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2011)
36
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2008)
97
Actual Study Completion Date  ICMJE June 21, 2010
Actual Primary Completion Date June 21, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00637052
Other Study ID Numbers  ICMJE ARRAY-520-211
C4371005 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

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