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A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

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

- 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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses

Outcome Time Frame:

First treatment until 30 days post last treatment

Safety Issue:


Principal Investigator

Harold Keer, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Exelixis, Inc. (Study Sponsor)


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

November 2007

Related Keywords:

  • Cancer
  • Solid Tumors



Mayo Clinic Rochester, Minnesota  55905
Stanford University Medical Center Stanford, California  94305-5408