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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00086528 |
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Date of registration:
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02/07/2004 |
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Primary sponsor: |
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Public title:
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Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
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Scientific title:
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A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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41 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00086528 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Harold Keer, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Exelixis, Inc. (Study Sponsor) |
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Key inclusion & exclusion criteria
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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 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 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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Drug: XL647
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Primary Outcome(s)
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To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses
[Time Frame: First treatment until 30 days post last treatment]
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Secondary Outcome(s)
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To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors
[Time Frame: At various time points between pre-treatment and post last treatment]
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To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat dose
[Time Frame: At various time points between pre-treatment and post last treatment]
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Secondary ID(s)
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XL647-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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