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

Conditions

• Astrocytic Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib — DRUG

Study Details

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.

Key Dates

Start date

Apr 30, 2010

Status verified

Feb 2026

Primary completion

May 31, 2011

Completion

Oct 31, 2013

Study Design

Enrollment

19 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 - cabozantinib, 25 mg
  Starting dose of 25 mg, once a day by mouth (po QD) continuously
• Experimental: Arm 2 - cabozantinib, 75 mg
  Starting dose of 75 mg, po QD, continuously
• Experimental: Arm 3 - cabozantinib, 125 mg followed by 50 mg
  Starting dose of 125 mg, po QD for 2 weeks, followed by 50 mg, po QD for the remainder of the treatment period.
• Experimental: Arm 4 - cabozantinib, 125 mg
  Initially, the starting dose was 125 mg, po QD for 2 weeks, followed by 1 week off. For the remainder of the treatment, the dosing frequency was reduced to 125 mg, po QD every 3 weeks, followed by 1 week of rest for the remainder of the treatment period.

Primary Outcome Measure

Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 13 months ]

Locations (17)