Who is sponsoring NCT00710736?

NCT00710736 is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.

What condition does NCT00710736 study?

NCT00710736 studies Advanced Cancer.

What drugs are being tested in NCT00710736?

Interventions: ARRY-334543, EGFR/ErbB2 inhibitor; oral, Capecitabine, 5-fluorouracil prodrug; oral.

What is the status of NCT00710736?

NCT00710736 is currently COMPLETED.

Last reviewed 2020-10-02 · How we verify

A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer

NCT00710736 Phase 1 COMPLETED

This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US and Canada will be enrolled in this study.

Details

Lead sponsor	Array Biopharma, now a wholly owned subsidiary of Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	29
Start date	2008-06
Completion	2011-04

Conditions

Advanced Cancer

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oral
Capecitabine, 5-fluorouracil prodrug; oral

Primary outcomes

Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine. — Duration of study
Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. — Duration of study
Characterize the pharmacokinetics (PK) of study drug and capecitabine. — Duration of study

Countries

United States, Canada