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A Phase 1 Dose Finding Study of the Safety and Pharmacokinetics of XL184 Administered Orally in Combination With Temozolomide and Radiation Therapy in the First Line Treatment of Subjects With Glioblastoma

Phase 1
18 Years
Open (Enrolling)
Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma

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Trial Information

A Phase 1 Dose Finding Study of the Safety and Pharmacokinetics of XL184 Administered Orally in Combination With Temozolomide and Radiation Therapy in the First Line Treatment of Subjects With Glioblastoma

Inclusion Criteria:

- Histologically confirmed diagnosis of Grade 4 astrocytic tumor, which includes
glioblastoma, giant cell glioblastoma, gliosarcoma, and glioblastoma with
oligodendroglial components.

- Must have had a partial or complete surgical resection of the Grade 4 astrocytic

- Subjects in Arm 1 must have had no previous treatment except surgery (ie, no previous
RT, local chemotherapy, or systemic therapy). Subjects must meet certain other
eligibility requirements.

- Subjects in Arm 2 must have completed a standard first line regimen of concurrent TMZ
and RT for newly diagnosed GB, followed by a rest phase, and has not had any other
previous treatment except surgery (including any other regimens of RT and local or
systemic chemotherapy). Subjects must meet certain other eligibility requirements.

- Subjects must be able to undergo serial MRIs (computerized tomography [CT] may not
substitute for magnetic resonance imaging [MRI]).

- Must be ≥ 18 years old.

- Must have a Karnofsky performance status of ≥ 70% and the ability to swallow whole

- Must have no other diagnosis of malignancy (except surgically excised non-melanoma
skin cancer or carcinoma in situ of the cervix, treated early stage prostate cancer,
or a malignancy diagnosed ≥ 2 years previously with no current evidence of disease
and no therapy within two years prior to enrollment on this study).

- Must be capable of understanding and complying with the protocol requirements and has
signed the informed consent document.

- Sexually active fertile subjects (male and female) must agree to use accepted methods
of contraception during the course of the study and for 3 months after the last dose
of study drug(s).

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

Exclusion Criteria:

- Subject has received prior systemic chemotherapy or RT (Arm 1) or prior systemic
chemotherapy other than TMZ (Arm 2), biologic agents, or any other type of
investigational agent for the treatment of brain tumors. Subjects who have
progressed on TMZ are not eligible.

- Subject has evidence of acute intracranial or intratumoral hemorrhage > Grade 1
either by MRI or CT scan. Subjects with resolving hemorrhage changes, punctate
hemorrhage, or hemosiderin may enter the study.

- Subject has serious intercurrent illness such as: hypertension despite optimal
treatment, or significant cardiac arrhythmias; or a recent history of serious disease
such as symptomatic congestive heart failure, or abdominal fistula or
gastrointestinal (GI) perforation within 6 months, prior to starting study treatment.

- Subject has had major surgery within 28 days prior to starting study treatment, or
had non water-tight dural closure during previous surgery, or has unhealed wounds
from previous surgery.

- Subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.

- Subject is pregnant or breastfeeding.

- Subject is known to be positive for the human immunodeficiency virus (HIV) (a test
for HIV at screening is not required).

- Subject has a previously-identified allergy or hypersensitivity to components of
either the XL184 or TMZ formulations.

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

Type of Study:


Study Design:

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

Outcome Measure:

Evaluate the safety and tolerability of oral administration of XL184 added to first-line treatment for subjects with newly diagnosed GB

Outcome Time Frame:

Assessed at every visit to the study clinic

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

April 2013

Related Keywords:

  • Glioblastoma
  • Giant Cell Glioblastoma
  • Gliosarcoma
  • Astrocytic tumor
  • Glioblastoma with oligodendroglial components
  • Glioblastoma
  • Gliosarcoma



MD Anderson Cancer CenterHouston, Texas  77030-4096
Beth Israel Medical CenterNew York, New York  10003
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of WashingtonSeattle, Washington  98195
Henry Ford Health SystemDetroit, Michigan  48202
UCLALos Angeles, California  90095
Duke University Medical Center; The Preston Robert Tisch Brain Tumor CenterDurham, North Carolina  27710
University of Virginia Health System/Division of Neuro-OncologyCharlottesville, Virginia  22908