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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

Primary Purpose

Astrocytic Tumors

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
XL184
Sponsored by
Exelixis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astrocytic Tumors focused on measuring Glioblastoma, Glioma, Brain Cancer, Brain Tumor, Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Outcomes

Primary Outcome Measures

In the Randomized Phase, to evaluate the preliminary efficacy and tolerability of multiple regimens of XL184
In the Expansion Phase, to evaluate the efficacy of XL184 treatment

Secondary Outcome Measures

To further evaluate the safety and tolerability of XL184 treatment during the entire treatment period
To further characterize the pharmacokinetic and pharmacodynamic parameters of XL184

Full Information

First Posted
February 12, 2010
Last Updated
July 28, 2014
Sponsor
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT01068782
Brief Title
Study of Multiple Doses and Regimens of XL184 (Cabozantinib) in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exelixis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astrocytic Tumors
Keywords
Glioblastoma, Glioma, Brain Cancer, Brain Tumor, Astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
XL184
Intervention Description
given orally as capsules
Primary Outcome Measure Information:
Title
In the Randomized Phase, to evaluate the preliminary efficacy and tolerability of multiple regimens of XL184
Time Frame
Assessed every 1-3 weeks, during study visits
Title
In the Expansion Phase, to evaluate the efficacy of XL184 treatment
Time Frame
Assessed every 6 weeks
Secondary Outcome Measure Information:
Title
To further evaluate the safety and tolerability of XL184 treatment during the entire treatment period
Time Frame
Assessed every 1-3 weeks, during study visits
Title
To further characterize the pharmacokinetic and pharmacodynamic parameters of XL184
Time Frame
Assessed every 3-4 weeks, during study visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
City
Amhearst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75426
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
City
Calgary
State/Province
Alberta
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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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

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