Study of XL647 Administered Orally Daily to Patients With Solid Tumors

Phase 1

Completed

• Conditions: Cancer

• Registration Number: NCT00336765
• Lead Sponsor: Kadmon Corporation, LLC

Brief Summary

The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-12
• Study First Submitted QC: 2006-06-12
• Study First Posted: 2006-06-14
• Study Start: 2006-07
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Subject has histologically confirmed malignancy that is metastatic or unresectable
• Subject has disease that is assessable by tumor marker, physical, or radiologic means
• Subject is at least 18 years old
• Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
• Subject has a life expectancy ≥ 3 months
• Subject has normal organ and marrow function
• Subject gives written informed consent
• Subject must use an accepted method of contraception during the study
• Female subjects of childbearing potential must have a negative pregnancy test

Exclusion Criteria

• Subject has received anticancer treatment within 30 days of first dose of XL647
• Subject has received another investigational agent within 30 days of first dose of XL647
• Subject has known brain metastases
• Subject has corrected QT interval (QTc) of > 0.45 seconds
• Subject is currently receiving anticoagulation therapy with warfarin
• Subject has uncontrolled intercurrent illness
• Subject is pregnant or breastfeeding
• Subject has known HIV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate safety, tolerability, and maximum tolerated dose of XL647	Inclusion until 30 days post last treatment

Secondary Outcome Measures

Name	Time	Method
Characterize pharmacokinetics and pharmacodynamic effects of XL647	At various time points from pre-dosing until post dosing
Evaluate preliminary tumor response	Inclusion until disease progression

Trial Locations

Locations (2)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States