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A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer, Lymphoma

Thank you

Trial Information

A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Advanced Malignancies


Inclusion Criteria:



- The subject has a histologically confirmed solid tumor that is metastatic or
unresectable, lymphoma, or multiple myeloma, and for which standard curative or
palliative measures do not exist or are no longer effective, and there are no known
therapies to prolong survival. Subjects treated at the MTD (once-weekly) must have a
diagnosis of metastice colorectal carcinoma, relapsed or refractory multiple myeloma,
non-small-cell lung cancer (NSCLC), or small cell lung cancer (SCLC). Certain other
eligibility requirements must also be met.

- The subject has disease that is assessable by tumor marker, clinical laboratory,
physical, or radiologic means.

- The subject is ≥18 years old.

- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

- The subject has adequate organ and marrow function.

- The subject is capable of understanding the informed consent document and has signed
the informed consent document.

- Sexually active subjects (male and female) must use medically acceptable methods of
contraception during the course of the study.

- Female subjects of childbearing potential must have a negative serum pregnancy test
at screening.

Exclusion Criteria:

- The subject has received anticancer treatment (eg, chemotherapy, radiotherapy,
cytokines, investigational agent, or hormones) within 14 days before the first dose
of study drug.

- The subject has received radiation to >25% of his or her bone marrow within 30 days
of treatment with XL228.

- The subject has not recovered to National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from adverse events (AEs) due to
investigational or other agents administered more than 14 days prior to study
enrollment.

- The subject has a primary brain tumor. Subjects with brain metastases are considered
eligible if the subject has not received radiation therapy for brain metastasis
within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more
weeks.

- The subject has an uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable
angina pectoris, or cardiac arrhythmia.

- The subject has a psychiatric illness or social situation that would limit compliance
with study requirements.

- The subject is pregnant or breastfeeding.

- The subject is known to be positive for the human immunodeficiency virus (HIV).

- The subject has a known allergy or hypersensitivity to components of the XL228
formulation.

- The subject is unable or unwilling to abide by the study protocol or cooperate fully
with the investigator or designee.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the safety and tolerability of XL228 administered as a once-weekly or twice-weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies.

Outcome Time Frame:

Assessed at periodic visits

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

XL228-002

NCT ID:

NCT00526838

Start Date:

September 2007

Completion Date:

June 2011

Related Keywords:

  • Cancer
  • Lymphoma
  • Solid Tumor
  • Multiple Myeloma
  • Lymphoma

Name

Location

Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Duke University Medical CenterDurham, North Carolina  27710
University of Michigan Health SystemAnn Arbor, Michigan  
UCLA Jonsson Comprehensive Cancer CenterLos Angeles, California  90095