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Study of Multiple Doses and Regimens of XL184 (Cabozantinib) in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse

Study Purpose

This is a study of multiple regimens of single-agent XL184 in subjects with grade IV astrocytic tumor in first or second relapse. The Randomized Phase of the study will evaluate the safety, tolerability, and preliminary efficacy of four XL184 dosing regimens in separate study arms. Subjects will be randomized to one of the study arms, which will not be blinded. After the Randomized Phase, additional subjects will be enrolled to further expand one study arm in the Expansion Phase.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01068782
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Exelixis
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Astrocytic Tumors
Arms & Interventions

Arms

Experimental: Arm 1

Experimental: Arm 2

Experimental: Arm 3

Experimental: Arm 4

Interventions

Drug: - XL184

given orally as capsules

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

Birmingham, Alabama, 35294

Encinitas, California

Status

Address

Encinitas, California, 92024

Pleasant Hill, California

Status

Address

Pleasant Hill, California, 94523

Chicago, Illinois

Status

Address

Chicago, Illinois, 60611

Chicago, Illinois

Status

Address

Chicago, Illinois, 60637

Boston, Massachusetts

Status

Address

Boston, Massachusetts, 02115

Detroit, Michigan

Status

Address

Detroit, Michigan, 48202

Minneapolis, Minnesota

Status

Address

Minneapolis, Minnesota, 55407

Amhearst, New York

Status

Address

Amhearst, New York, 14226

Rochester, New York

Status

Address

Rochester, New York, 14642

Cleveland, Ohio

Status

Address

Cleveland, Ohio, 44195

Hershey, Pennsylvania

Status

Address

Hershey, Pennsylvania, 17033

Dallas, Texas

Status

Address

Dallas, Texas, 75246

Dallas, Texas

Status

Address

Dallas, Texas, 75426

San Antonio, Texas

Status

Address

San Antonio, Texas, 78229

Charlottesville, Virginia

Status

Address

Charlottesville, Virginia, 22908

Seattle, Washington

Status

Address

Seattle, Washington, 98122

International Sites

Calgary, Alberta, Canada

Status

Address

Calgary, Alberta,

Montreal, Quebec, Canada

Status

Address

Montreal, Quebec,

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