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

Myelodysplastic Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496495
• Other study ID #: ARRAY-614-112
• Status: Completed
• Phase: Phase 1
• Start date: January 2012
• Est. completion date: March 18, 2015

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 syndromes (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 in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 50 patients from the US will be enrolled in Part 1 (Completed).

In the second part of the study, patients will receive the best dose of study drug 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 30 patients from the US will be enrolled in Part 2 (Completed).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 18, 2015
• Est. primary completion date: December 2014
• 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) of 0, 1 or 2.

• Adequate liver and renal function.

• Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

• History of bone marrow transplant.

• Treatment for MDS other than transfusions or a stable dose (= 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug.

• 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 prolonged side effects.

• Treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug.

• Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to > 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug.

• Treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug.

• 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	Emory University, Winship Cancer Institute	Atlanta	Georgia
United States	Cleveland Clinic	Cleveland	Ohio
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	Establish the maximum tolerated dose (MTD) of study drug.		Part 1, 9 months
Primary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.		Part 1, 9 months; Part 2, 9 months
Primary	Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.		Part 1, 9 months; Part 2, 9 months
Secondary	Assess the efficacy of the study drug in terms of response, time to response, duration of response, overall survival, hematologic improvement and platelet transfusion independence/reduction.		Part 1, 9 months; Part 2, 9 months