NCT00086528

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

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Kadmon Corporation, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is as follows: * To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors. The secondary objectives of this study are as follows: * To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors, * To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors. The exploratory objective of this study is as follows: * To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells. In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from this part of the study: * Long-term safety and tolerability of XL647 after repeat administration, * Tumor response after repeat administration of XL647.

Conditions

• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-06-01
• Primary completion: 2007-07-01
• Completion: 2007-11-01
• First posted: 2004-07-07
• Last updated: 2022-05-13

Locations

2 sites across 1 country: United States