Study of XL647 Administered Orally Daily to Patients With Solid Tumors
NCT ID: NCT00336765
Last Updated: 2022-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2006-07-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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XL647
Tablets supplied in 50-mg strength administered orally daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Kadmon Corporation, LLC
INDUSTRY
Responsible Party
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Locations
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Stanford University Medical Center
Stanford, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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.
Other Identifiers
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XL647-002
Identifier Type: -
Identifier Source: org_study_id
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