- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00637052
A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
A Phase 1/2 Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
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 Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University School of Medicine, Winship Cancer Center
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Texas
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Houston, Texas, United States, 77030
- University of Texas, M.D. Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARRY-520
|
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Establish the maximum tolerated dose (MTD) of the study drug.
Time Frame: Part 1
|
Part 1
|
Characterize the pharmacokinetics (PK) of the study drug.
Time Frame: Part 1
|
Part 1
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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
|
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
|
Part 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the efficacy of the study drug in terms of incidence of CR and CRp.
Time Frame: Part 1 and Part 2
|
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
|
Part 3
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARRAY-520-211
- C4371005 (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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