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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01068782
Recruitment Status : Completed
First Posted : February 15, 2010
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
Exelixis

Tracking Information
First Submitted Date  ICMJE February 12, 2010
First Posted Date  ICMJE February 15, 2010
Last Update Posted Date July 30, 2014
Study Start Date  ICMJE April 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
  • 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 ]
  • In the Expansion Phase, to evaluate the efficacy of XL184 treatment [ Time Frame: Assessed every 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
  • 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 ]
  • To further characterize the pharmacokinetic and pharmacodynamic parameters of XL184 [ Time Frame: Assessed every 3-4 weeks, during study visits ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Multiple Doses and Regimens of XL184 (Cabozantinib) in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Astrocytic Tumors
Intervention  ICMJE Drug: XL184
given orally as capsules
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: XL184
  • Experimental: Arm 2
    Intervention: Drug: XL184
  • Experimental: Arm 3
    Intervention: Drug: XL184
  • Experimental: Arm 4
    Intervention: Drug: XL184
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2014)
19
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2010)
186
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01068782
Other Study ID Numbers  ICMJE XL184-205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Exelixis
Study Sponsor  ICMJE Exelixis
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Exelixis
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP