Back to resultsXL-184+Abiraterone in Post-Chemo CRPC
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cabozantinib
Abiraterone
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Castration Resistant, Post Chemotherapy
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Cabozantinib and abiraterone
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose
To define the MTD of cabozantinib in combination with abiraterone
Secondary Outcome Measures
Definition of a Dosing Regimen
To define a dosing regimen of abiraterone and cabozantinib suitable for further evaluation based on long term toxicity and efficacy data
Full Information
NCT ID
NCT01574937
First Posted
April 8, 2012
Last Updated
August 5, 2021
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01574937
Brief Title
XL-184+Abiraterone in Post-Chemo CRPC
Official Title
A Dose Finding Clinical Trial of Cabozantinib (XL 184) Administered in Combination With Abiraterone in Castration Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2012 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Castration Resistant, Post Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Cabozantinib and abiraterone
Intervention Type
Drug
Intervention Name(s)
Cabozantinib
Other Intervention Name(s)
XL 184
Intervention Description
28 day cycle
Intervention Type
Drug
Intervention Name(s)
Abiraterone
Other Intervention Name(s)
Zytiga
Intervention Description
28 day cycle
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Description
To define the MTD of cabozantinib in combination with abiraterone
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Definition of a Dosing Regimen
Description
To define a dosing regimen of abiraterone and cabozantinib suitable for further evaluation based on long term toxicity and efficacy data
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Sweeney, MBBS
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
XL-184+Abiraterone in Post-Chemo CRPC
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