Clinical Trial: Safety and Pharmacokinetics of XL647 Administered Orally to Subjects with Solid Tumors


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Sponsored by:	Exelixis
Information provided by:	Exelixis

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:

Condition	Treatment or Intervention	Phase
Cancer	Drug: XL647	Phase I

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

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).