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