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XL-184+Abiraterone in Post-Chemo CRPC

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. Identifier: NCT01574937
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : February 9, 2021
Information provided by (Responsible Party):
Christopher Sweeney, MBBS, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE April 8, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE April 3, 2012
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2012)
Maximum Tolerated Dose [ Time Frame: 2 years ]
To define the MTD of cabozantinib in combination with abiraterone
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2012)
Definition of a Dosing Regimen [ Time Frame: 2 years ]
To define a dosing regimen of abiraterone and cabozantinib suitable for further evaluation based on long term toxicity and efficacy data
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 XL-184+Abiraterone in Post-Chemo CRPC
Official Title  ICMJE A Dose Finding Clinical Trial of Cabozantinib (XL 184) Administered in Combination With Abiraterone in Castration Resistant Prostate Cancer
Brief Summary

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA (U.S. Food and Drug Administration) may not have approved this drug for use in participants, including people with your type of cancer.

In this research study, we are testing the safety of XL184 at different dose levels. XL184 is a new study drug, which is taken by mouth. Laboratory studies have shown that XL184 may prevent tumor growth by stopping the formation of blood vessels inside the tumor and also shrink tumors.

This drug has been used in early-stage studies and is also currently being studied in other trials. Information from those other research studies suggests that XL184 may help to slow or stop tumor growth including prostate cancer. We will also be taking blood and urine tests to look at how your body processes the drug.

Detailed Description

The following procedures will be performed during this study. On Day 1 for every cycle (28 days/4 weeks)-The following will be undertaken prior to initiating study therapy and on day 1 of every subsequent cycle: A medical history, physical exam, performance status, blood tests, urine test.

Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.

We will actively monitor your condition for up to 30 days after you come off the study. If you come off study for a side effect we will monitor your condition until the resolution or stabilization of the side effect

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Cabozantinib
    28 day cycle
    Other Name: XL 184
  • Drug: Abiraterone
    28 day cycle
    Other Name: Zytiga
Study Arms  ICMJE Experimental: Treatment Arm
Cabozantinib and abiraterone
  • Drug: Cabozantinib
  • Drug: Abiraterone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2012)
Actual Study Completion Date  ICMJE July 31, 2020
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CRPC with up to 2 prior chemotherapy regimens
  • Progressive disease on CT, MRI or bone scan per mRECIST
  • Has recovered to baseline/CTCAE less than or equal to Grade 1 from toxicities related to prior treatment (except alopecia)
  • Agree to use accepted barrier method of contraception

Exclusion Criteria:

  • Cytotoxic chemotherapy within 3 weeks
  • Prior treatment with cabozantinib or other c-MET inhibitor
  • Prior therapy with a lyase inhibitor
  • Concurrent use of hormonal therapies other than LHRH analogue or orchiectomy
  • Received radiation therapy to thoracic cavity or GI tract within 3 months, to bone or brain metastasis within 2 weeks or to any other site within 4 weeks of first dose of study drug
  • Prior treatment with a small molecular kinase inhibitor within 2 weeks of study entry
  • Received another investigational product within 28 days prior to study entry
  • Active brain metastases or epidural disease
  • Requires concomitant treatment in therapeutic doses with warfarin or warfarin-related agents
  • No uncontrolled significant intercurrent or recent illness
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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 United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01574937
Other Study ID Numbers  ICMJE 11-441
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christopher Sweeney, MBBS, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Sweeney, MBBS Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date February 2021

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