Status:
COMPLETED
Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
Lead Sponsor:
Kadmon Corporation, LLC
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is as follows: * To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors. The seco...
Eligibility Criteria
Inclusion
- The subject has a histologically confirmed malignancy that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective,
- The subject has disease that is assessable by tumor marker, physical, or radiologic means,
- The subject is ≥18 years old,
- There have been at least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last treatment regimen included BCNU or mitomycin C),
- The subject has an ECOG performance status ≤2 (Karnofsky \>60%),
- The subject has a life expectancy of ≥3 months,
- The subject has normal organ and marrow function (hemoglobin \>10g/dL, leukocytes \>3,000/mL, absolute neutrophil count \>1,500/µL, platelets \>100,000/µL, total bilirubin within normal institutional limits of normal,AST (SGOT)/ALT(SGPT) \<2.5 times the upper limit of normal, and creatinine within normal limits,
- The subject is capable of understanding and complying with the protocol and has signed the informed consent document,
- Sexually active subjects (both male and female) must use an accepted method of contraception during the course of the study,
- Female subjects of childbearing potential (pre-menopausal) must have a negative pregnancy test.
Exclusion
- The subject has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or has not recovered from AEs due to agents administered more than 4 weeks earlier,
- The subject has received another investigational agent within 30 days (or 5.5 half-lives) of the first dose of study drug,
- The subject has known brain metastases,
- The subject has a corrected QT interval (QTc) of \>0.44 seconds,
- The subject has a history of allergic reactions attributed to aspartame or to any other component in the formulation vehicle,
- The subject has an uncontrolled intercurrent illness including,but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements,
- The subject is pregnant or nursing,
- The subject is known to be positive for the human immunodeficiency virus (HIV).
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00086528
Start Date
June 1 2004
End Date
November 1 2007
Last Update
May 13 2022
Active Locations (2)
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1
Stanford University Medical Center
Stanford, California, United States, 94305
2
Mayo Clinic
Rochester, Minnesota, United States, 55905