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

NCT01068782 | Terminated Phase 2 Results DMC

• 1 other identifier: XL184-205
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 19

Brief 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.

Conditions

Astrocytic Tumors

Keywords

Glioblastoma; Glioma; Brain Cancer; Brain Tumor; Astrocytoma

Outcome Measures

Primary Outcomes (2)

• 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'.

  Up to 13 months

• 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.

  Up to 13 months

Secondary Outcomes (1)

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

  Month 6

Study Arms (4)

Arm 1 - cabozantinib, 25 mg

EXPERIMENTAL

Starting dose of 25 mg, once a day by mouth (po QD) continuously

Drug: Cabozantinib

Arm 2 - cabozantinib, 75 mg

EXPERIMENTAL

Starting dose of 75 mg, po QD, continuously

Drug: Cabozantinib

Arm 3 - cabozantinib, 125 mg followed by 50 mg

EXPERIMENTAL

Starting dose of 125 mg, po QD for 2 weeks, followed by 50 mg, po QD for the remainder of the treatment period.

Drug: Cabozantinib

Arm 4 - cabozantinib, 125 mg

EXPERIMENTAL

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.

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

Also known as: XL-184

Arm 1 - cabozantinib, 25 mg; Arm 2 - cabozantinib, 75 mg; Arm 3 - cabozantinib, 125 mg followed by 50 mg; Arm 4 - cabozantinib, 125 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Exelixis: lead

Study Sites (19)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Encinitas, California, 92024, United States

Location

Unknown Facility

Pleasant Hill, California, 94523, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Detroit, Michigan, 48202, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55407, United States

Location

Unknown Facility

Amherst, New York, 14226, United States

Location

Unknown Facility

Rochester, New York, 14642, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Dallas, Texas, 75426, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Charlottesville, Virginia, 22908, United States

Location

Unknown Facility

Seattle, Washington, 98122, United States

Location

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Glioblastoma; Glioma; Brain Neoplasms; Astrocytoma

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

The enrollment in this study was terminated for business development reasons before enrolling one third of the expected participant population. No efficacy data were collected and limited safety data were collected.

Results Point of Contact

• Title: Exelixis Medical Information
• Organization: Exelixis, Inc.

druginfo@exelixis.com

855-292-3935

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 15, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: October 1, 2013
• Last Updated: February 25, 2026
• Results First Posted: February 25, 2026

Record last verified: 2026-02

Locations

US (17); CA (2)