Who is sponsoring NCT01316822?

NCT01316822 is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.

What condition does NCT01316822 study?

NCT01316822 studies Metastatic Cancer.

What drugs are being tested in NCT01316822?

Interventions: ARRY-382, cFMS inhibitor; oral.

What is the status of NCT01316822?

NCT01316822 is currently COMPLETED.

Last reviewed 2020-09-17 · How we verify

A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers

NCT01316822 Phase 1 COMPLETED

This is a Phase 1 study during which patients with advanced cancer will receive investigational study drug ARRY-382. 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. Patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in this study.

Details

Lead sponsor	Array Biopharma, now a wholly owned subsidiary of Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	26
Start date	2011-03
Completion	2012-10

Conditions

Metastatic Cancer

Interventions

ARRY-382, cFMS inhibitor; oral

Primary outcomes

Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms. — Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
Establish the maximum tolerated dose (MTD) of study drug. — The MTD will be based on Cycle 1 (28 days).
Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites. — Safety will be characterized for the duration of time that each patient stays on study; estimated one year.

Countries

United States