A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916227
• Other study ID #: ARRAY-614-111
• Status: Completed
• Phase: Phase 1
• Start date: June 2009

Study information

• Verified date: September 2020
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 60 patients from the US will be enrolled in Part 1 (Completed).

In the second part of this study, patients will receive the best dose of study drug, given either with food or without food, determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria (Part 1 and Part 2):

• Diagnosis of MDS by bone marrow biopsy.

• International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.

• May have received prior therapy for MDS.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.

• Adequate liver and renal function.

• Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

• History of bone marrow transplant.

• Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.

• Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have late side effects.

• Known positive serology for the human immunodeficiency virus (HIV), hepatitis C and/or active hepatitis B.

• Additional criteria exist.

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• ARRY-614, p38/Tie2 inhibitor; oral
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

Locations

Country	Name	City	State
United States	Winship Cancer Institute	Atlanta	Georgia
United States	MD Anderson Cancer Center	Houston	Texas
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Array Biopharma, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.		Part 1, one year; Part 2, one year
Primary	Establish the maximum tolerated dose (MTD) of the study drug.		Part 1, one year
Primary	Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.		Part 1, one year; Part 2, one year
Secondary	Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.		Part 1, one year; Part 2, one year