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Astrocytic TumorsPhase 2NCT01068782

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

A Phase 2 study testing Cabozantinib in people with Astrocytic Tumors, run by Exelixis at 19 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Astrocytic Tumors
What is being tested?
Cabozantinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
19 sitesin 2 countries
Study dates
Apr 2010to Oct 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States17 sites

  • Study site

    Amherst, New York, 14226

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Dallas, Texas, 75246

  • Study site

    Dallas, Texas, 75426

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Encinitas, California, 92024

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Minneapolis, Minnesota, 55407

  • Study site

    Pleasant Hill, California, 94523

  • Study site

    Rochester, New York, 14642

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Seattle, Washington, 98122

Other trials in United States

Canada2 sites

  • Study site

    Calgary, Alberta

  • Study site

    Montreal, Quebec

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

The goal of this clinical trial is to learn if the drug cabozantinib works for people with astrocytic tumors. It also was designed to learn about the safety of cabozantinib. The main questions are:

  1. Does cabozantinib work and how well do patients tolerate the drug for over 12 weeks.
  2. Was the drug safe and how well could patients tolerate treatment for the entire treatment period.

Participants were assigned to one of the four treatment groups:

Arm 1. Take cabozantinib at a dose of 25 mg once every day (po QD) continuously until progression.

Arm 2. Take cabozantinib at a dose of 75 mg once every day continuously until progression.

Arm 3. Take cabozantinib at a dose of 125 mg once every day for 2 weeks, followed by 50 mg every day (po QD) for the remainder of the treatment period;

Arm 4. Take cabozantinib at a dose of 125 mg once every day for 2 weeks, followed by 1 week off. For the remainder of the treatment period, patients received cabozantinib at a dose of 125 mg once every day for three weeks followed by one week of rest.

Being tested
Cabozantinib
Keywords
Glioblastoma, Glioma, Brain Cancer, Brain Tumor, Astrocytoma
Medical subject headings
Glioblastoma, Glioma, Brain Neoplasms, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01068782
Study groupRoleWhat they receive
Arm 1 - cabozantinib, 25 mgExperimentalStarting dose of 25 mg, once a day by mouth (po QD) continuously
Receives: Drug: Cabozantinib
Arm 2 - cabozantinib, 75 mgExperimentalStarting dose of 75 mg, po QD, continuously
Receives: Drug: Cabozantinib
Arm 3 - cabozantinib, 125 mg followed by 50 mgExperimentalStarting dose of 125 mg, po QD for 2 weeks, followed by 50 mg, po QD for the remainder of the treatment period.
Receives: Drug: Cabozantinib
Arm 4 - cabozantinib, 125 mgExperimentalInitially, 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.
Receives: Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    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'.

    Measured: Up to 13 months

  2. Expansion Phase: Objective Response Rate (ORR)

    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.

    Measured: Up to 13 months

Secondary outcomes (1)

  1. Expansion Phase: Progression Free Survival at 6 Months as Per Independent Radiology Facility

    Progression-free survival at 6 months (PFS6) was defined as the proportion of participants alive and progression-free 182 days after Study Day 1. The sponsor terminated the study early due to business reasons before entering the expansion phase. As such, no data were collected for efficacy analyses.

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionMay 2011
  4. Study completionOct 2013

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01068782
Sponsor's protocol ID
XL184-205
Status last verified
Feb 2026
First submitted
12 Feb 2010
Last updated
25 Feb 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib in people with Astrocytic Tumors, run by Exelixis at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01068782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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