Study of XL647 Administered Orally Daily to Patients With Solid Tumors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336765
• Other study ID #: XL647-002
• Status: Completed
• Phase: Phase 1
• Start date: July 2006
• Est. completion date: September 2010

Study information

• Verified date: May 2022
• Source: Kadmon Corporation, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• XL647
Tablets supplied in 50-mg strength administered orally daily

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Kadmon Corporation, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Das M, Padda SK, Frymoyer A, Molina J, Adjei A, Lensing JL, Miles D, Sikic BI, Wakelee HA. A safety, tolerability, and pharmacokinetic analysis of two phase I studies of multitargeted small molecule tyrosine kinase inhibitor XL647 with an intermittent and continuous dosing schedule in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2018 Sep;82(3):541-550. doi: 10.1007/s00280-018-3646-0. Epub 2018 Jul 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety, tolerability, and maximum tolerated dose of XL647		Inclusion until 30 days post last treatment
Secondary	Characterize pharmacokinetics and pharmacodynamic effects of XL647		At various time points from pre-dosing until post dosing
Secondary	Evaluate preliminary tumor response		Inclusion until disease progression