Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First … (NCT01068782) | Clinical Trial Compass
TerminatedPhase 2
Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse
Stopped: Enrollment in this study was terminated for business development reasons before completing one third of the expected subject population, no formal statistical testing was performed.
United States19 participantsStarted 2010-04
Plain-language summary
This study was conducted in subjects with grade IV astrocytic tumors (a type of cancer that can occur in the brain or spinal cord) in first or second relapse.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
What they're measuring
1
Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)