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A Phase 2 Non-Comparative Randomized Open-Label Study of Multiple Regimens of Single-Agent XL184 in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Astrocytic Tumors

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Trial Information

A Phase 2 Non-Comparative Randomized Open-Label Study of Multiple Regimens of Single-Agent XL184 in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse


Inclusion Criteria:



- The subject has histologically confirmed diagnosis at any time of grade IV astrocytic
tumor as determined by the investigator. Tumor samples will be required for pathology
review.

- The subject has received prior standard radiation for any grade astrocytic tumor.

- The subject has received prior temozolomide (Temodar) therapy

- The subject has had one or two progressions as grade IV astrocytic tumor from any
grade, as determined by investigator

- The subject must have a qualifying brain MRI scan within a specific timeframe prior
to start of study treatment

- For subjects with recent tumor resection or biopsy, starting on study must occur a
specified amount of time after the surgery and the subject must have recovered from
the effects of surgery

- The subject has a Karnofsky Performance Status ≥ 70% and has the ability to swallow
whole capsules

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

- The subject has adequate organ and marrow function

- Sexually active subjects (male and female) must agree to use medically accepted
methods of contraception during the course of the study and for 6 months following
discontinuation of study treatment

- The subject has had no other diagnosis of malignancy (certain exceptions apply)

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

Exclusion Criteria:

- The subject has received certain prior anticancer therapies within a certain amount
of time before starting study treatment

- The subject is receiving warfarin (or other coumarin derivatives) and is unable to
switch to low molecular weight heparin

- The subject has evidence of acute intracranial or intratumoral hemorrhage either by
MRI or CT scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or
hemosiderin are eligible

- The subject is unable to undergo MRI scan (eg, has pacemaker)

- The subject has received enzyme-inducing anti-epileptic agents within a certain time
prior to starting study treatment (eg, carbamazepine, phenytoin, phenobarbital,
primidone)

- The subject has not recovered to National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) v3.0 Grade ≤ 1 from AEs (except alopecia and
lymphopenia) due to surgery, or other medications that were administered prior to
study start

- The subject has evidence of unhealed wounds

- The subject is pregnant or breast-feeding

- The subject has serious intercurrent illness or a recent history of serious disease

- The subject has inherited bleeding diathesis or coagulopathy (disease affecting how
blood clots) with the risk of bleeding

- The subject has a history of any medical or surgical conditions (eg, stomach or
intestinal surgery or resection) that would potentially interfere with or alter
gastrointestinal function

- The subject has a history of idiopathic pulmonary fibrosis or interstitial lung
disease

- The subject has received any live virus vaccine or any inactivated vaccine within a
certain amount of time before starting study treatment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

In the Randomized Phase, to evaluate the preliminary efficacy and tolerability of multiple regimens of XL184

Outcome Time Frame:

Assessed every 1-3 weeks, during study visits

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

XL184-205

NCT ID:

NCT01068782

Start Date:

April 2010

Completion Date:

December 2012

Related Keywords:

  • Astrocytic Tumors
  • Glioblastoma
  • Glioma
  • Brain Cancer
  • Brain Tumor
  • Astrocytoma
  • Astrocytoma
  • Glioblastoma

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Birmingham, Alabama  35294
Fountain Valley, California  92708
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Boston, Massachusetts