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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01068782
First received: February 12, 2010
Last updated: July 28, 2014
Last verified: July 2014
  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.


Condition Intervention Phase
Astrocytic Tumors
Drug: XL184
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Exelixis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • In the Expansion Phase, to evaluate the efficacy of XL184 treatment [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To further characterize the pharmacokinetic and pharmacodynamic parameters of XL184 [ Time Frame: Assessed every 3-4 weeks, during study visits ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2010
Study Completion Date: October 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: XL184
given orally as capsules
Experimental: Arm 2 Drug: XL184
given orally as capsules
Experimental: Arm 3 Drug: XL184
given orally as capsules
Experimental: Arm 4 Drug: XL184
given orally as capsules

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068782

Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Encinitas, California, United States, 92024
Pleasant Hill, California, United States, 94523
United States, Illinois
Chicago, Illinois, United States, 60637
Chicago, Illinois, United States, 60611
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis, Minnesota, United States, 55407
United States, New York
Amhearst, New York, United States, 14226
Rochester, New York, United States, 14642
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
United States, Texas
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75426
San Antonio, Texas, United States, 78229
United States, Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Seattle, Washington, United States, 98122
Canada, Alberta
Calgary, Alberta, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sponsors and Collaborators
Exelixis
  More Information

No publications provided

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01068782     History of Changes
Other Study ID Numbers: XL184-205
Study First Received: February 12, 2010
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Exelixis:
Glioblastoma
Glioma
Brain Cancer
Brain Tumor
Astrocytoma

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Neoplasms
Glioma
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on October 21, 2014