Clinical trial NCT00916227: A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myelodysplastic Syndromes
Keywords: Low or Intermediate-1 Risk Myelodysplastic Syndrome
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2009-06-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Part 1, one year; Part 2, one year
measure: Establish the maximum tolerated dose (MTD) of the study drug.
timeFrame: Part 1, one year
measure: Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.
timeFrame: Part 1, one year; Part 2, one year
Secondary outcomes:
measure: Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.
timeFrame: Part 1, one year; Part 2, one year
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: