Study of XL647 Administered Orally Daily to Patients With Solid Tumors - Full Text View

Sponsored by:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00336765

Purpose

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.

Condition	Intervention	Phase
Cancer	Drug: XL647	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors

Further study details as provided by Exelixis:

Primary Outcome Measures:

Evaluate safety, tolerability, and maximum tolerated dose of XL647 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Characterize pharmacokinetics and pharmacodynamic effects of XL647 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
Evaluate preliminary tumor response [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: XL647 Tablets supplied in 50-mg strengths administered orally daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Subjects 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336765

Locations

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Exelixis

More Information

Responsible Party:	Exelixis, Inc. ( Harold Keer, MD/Vice President, Clinical Research )
Study ID Numbers:	XL647-002
Study First Received:	June 12, 2006
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00336765
Health Authority:	United States: Food and Drug Administration

Keywords provided by Exelixis:

solid tumors

ClinicalTrials.gov processed this record on January 16, 2009