A Phase 1/2 interventional study of ARRY-520, KSP(Eg5) inhibitor; intravenous in Advanced MDS and Acute Myeloid Leukemia, sponsored by Pfizer. Completed at 2 sites in United States. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by Pfizer · Phase 1/2, Interventional, and Treatment
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 Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 36 is close to the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria (Part 2):
Key Exclusion Criteria (Part 2):
Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
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
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
Plan to share: Yes — 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.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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