NCT01068782Phase 2Terminated

Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse

Study sponsor: Exelixis

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2011-05Actual

Enrollment · participants19Actual

Source updated2026-02-25Last update listed in the registry record

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Posted 2026-02-25 · 2 fields changed

Primary outcomes · main study measures

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− Previous value

measure: In the Randomized Phase, to evaluate the preliminary efficacy and tolerability of multiple regimens of XL184; measure: In the Expansion Phase, to evaluate the efficacy of XL184 treatment

+ Updated value

measure: Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs); measure: Expansion Phase: Objective Response Rate (ORR)

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Recruitment status

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Completed

+ Updated value

Terminated

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Study details

Conditions studied

Astrocytic Tumors

Treatments or interventions studied

CabozantinibDrugAlso known as XL-184

Primary outcomes · main study measures

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measure: Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs); description: An AE was defined as any event with an onset date on or after the date of first dose of study drug, or any ongoing event on the date of first dose that worsened in severity after the date of first dose. TEAEs were defined as AEs that started on or after the first administration of study drug up to the date of last dose plus 30 days. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.; timeFrame: Up to 13 months; measure: Expansion Phase: Objective Response Rate (ORR); description: ORR was defined as the number of participants for whom the best overall response at the time of data cutoff is confirmed complete response (CR) or confirmed partial response (PR) as assessed per modified Response Assessment in Neuro-Oncology (RANO) criteria. CR = Disappearance of all enhancing target lesion(s) and no glucocorticoids (other than a physiologic replacement dose of a maximum of 1.2 mg dexamethasone equivalent dose per day) taken for the 5 days immediately preceding the date of the current magnetic resonance imaging (MRI). PR = ≥50% decrease in the sum of the products of perpendicular diameters of all target enhancing lesions on the current MRI scan compared to the baseline MRI scan and glucocorticoids stable or decreased. The sponsor terminated the study early due to business reasons before entering the expansion phase. As such, no data were collected for efficacy analyses.; timeFrame: Up to 13 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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