XL-184+Abiraterone in Post-Chemo CRPC

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christopher Sweeney, MBBS, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01574937
First received: April 8, 2012
Last updated: July 20, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Cabozantinib
Drug: Abiraterone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose Finding Clinical Trial of Cabozantinib (XL 184) Administered in Combination With Abiraterone in Castration Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To define the MTD of cabozantinib in combination with abiraterone


Secondary Outcome Measures:
  • Definition of a Dosing Regimen [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To define a dosing regimen of abiraterone and cabozantinib suitable for further evaluation based on long term toxicity and efficacy data


Estimated Enrollment: 27
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Cabozantinib and abiraterone
Drug: Cabozantinib
28 day cycle
Other Name: XL 184
Drug: Abiraterone
28 day cycle

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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: NCT01574937

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massahcusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Christopher Sweeney, MBBS, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01574937     History of Changes
Other Study ID Numbers: 11-441
Study First Received: April 8, 2012
Last Updated: July 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Castration Resistant
Post Chemotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014