Study of XL999 in Adults With Solid Tumors | NCT00104117 | Trialant

Study of XL999 in Adults With Solid Tumors | NCT00104117 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XL999	Drug	XL999 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors		Inclusion until 30 days post last treatment

Secondary Outcomes

Measure	Description	Time Frame
To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors		Various timepoints from pre-dosing until 48 hours post dose.
To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg.

Contacts/Locations Module