- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00336765
Study of XL647 Administered Orally Daily to Patients With Solid Tumors
May 9, 2022 updated by: Kadmon Corporation, LLC
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University Medical Center
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate safety, tolerability, and maximum tolerated dose of XL647
Time Frame: Inclusion until 30 days post last treatment
|
Inclusion until 30 days post last treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Characterize pharmacokinetics and pharmacodynamic effects of XL647
Time Frame: At various time points from pre-dosing until post dosing
|
At various time points from pre-dosing until post dosing
|
Evaluate preliminary tumor response
Time Frame: Inclusion until disease progression
|
Inclusion until disease progression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
June 12, 2006
First Submitted That Met QC Criteria
June 12, 2006
First Posted (Estimate)
June 14, 2006
Study Record Updates
Last Update Posted (Actual)
May 13, 2022
Last Update Submitted That Met QC Criteria
May 9, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XL647-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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