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

Status:	Recruiting
Conditions:	Blood Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	10/19/2013
Start Date:	January 2012
Contact:	Array BioPharma Clinical Trial Call Center
Phone:	303-381-6604

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
(Recruiting).

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 (Not yet recruiting; Expansion optional, as
per protocol).

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.

We found this trial at

sites

Moffitt Cancer Center

12902 Usf Magnolia Drive
Tampa, Florida 33612

(888) 663-3488