Safety and Pharmacokinetics of XL647 Administered Orally to Subjects with Solid Tumors
This study is currently recruiting patients.
Sponsored by: |
Exelixis |
Information provided by: |
Exelixis |
Purpose
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 (up to 11 different
dose levels) in subjects with solid tumors.
The secondary objectives of this study are as follows:
- To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses (up to 11 different
dose levels) in subjects with solid tumors,
- To estimate renal elimination of XL647 administered orally as a single dose (up to 11 different dose levels) in subjects with
solid tumors.
The exploratory objective of this study is as follows:
- To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells.
In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from
this part of the study:
- Long-term safety and tolerability of XL647 after repeat administration,
- Tumor response after repeat administration of XL647.
Condition
|
Treatment or Intervention |
Phase |
Cancer
|
Drug: XL647
|
Phase I
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment, Non-Randomized, 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 to Subjects with Solid Tumors
Further Study Details:
Expected Total Enrollment:
66
Study start: June 2004
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
Inclusion Criteria:
- 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), 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 Criteria:
- 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).
Location
and Contact
Information
California Stanford University Medical Center, Stanford,
California,
94305,
United States; Recruiting
Minnesota Mayo Clinic, Rochester,
Minnesota,
55905,
United States; Recruiting
Study chairs or principal investigators
Harold Keer, M.D., Ph.D., Study Director, Exelixis, Inc. (Study Sponsor)
More Information
Study ID Numbers:
XL647-001
Record last reviewed:
July 2004
Record first received:
July 2, 2004
ClinicalTrials.gov Identifier:
NCT00086528Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10