Clinical trial · Interventional
Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytic Tumors | Astrocytic Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1 - cabozantinib, 25 mg
- description
- Starting dose of 25 mg, once a day by mouth (po QD) continuously
- interventionNames
- Drug: Cabozantinib
- type
- EXPERIMENTAL
- label
- Arm 2 - cabozantinib, 75 mg
- description
- Starting dose of 75 mg, po QD, continuously
- interventionNames
- Drug: Cabozantinib
- type
- EXPERIMENTAL
- label
- Arm 3 - cabozantinib, 125 mg followed by 50 mg
- description
- Starting dose of 125 mg, po QD for 2 weeks, followed by 50 mg, po QD for the remainder of the treatment period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available