Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

July 31, 2007

Study Completion Date

November 30, 2007

Conditions
Cancer
Interventions
DRUG

XL647

Administered orally as a solution with mass-based dosing in early cohorts or as 50-mg tablets at a fixed dose at the MTD. A minimum of 3 subjects was planned for each dosing cohort with dose escalation dependent on subject tolerance of the prior dose. During the Treatment Period, subjects in each cohort were administered a single dose of XL647 on Day 1 followed by a 72-hour period of observation. If there were no XL647-related dose limiting toxicities, subjects received 5 daily doses of XL647 on Days 4-8. Twenty-one days after the initial dose, in the absence of unacceptable toxicity or disease progression, subjects could enter a Treatment Extension Period that consisted of repeated 2-week cycles of five oral doses of XL647 followed by a 9-day observation period.

Trial Locations (2)

55905

Mayo Clinic, Rochester

94305

Stanford University Medical Center, Stanford

All Listed Sponsors
lead

Kadmon Corporation, LLC

INDUSTRY

NCT00086528 - Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors | Biotech Hunter | Biotech Hunter