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A Dose Finding Clinical Trial of Cabozantinib (XL 184) Administered in Combination With Abiraterone in Castration Resistant Prostate Cancer

Phase 1
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Dose Finding Clinical Trial of Cabozantinib (XL 184) Administered in Combination With Abiraterone in Castration Resistant Prostate Cancer

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

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

- No uncontrolled significant intercurrent or recent illness

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

To define the MTD of cabozantinib in combination with abiraterone

Outcome Time Frame:

2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

April 2014

Related Keywords:

  • Prostate Cancer
  • Castration Resistant
  • Post Chemotherapy
  • Prostatic Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massahcusetts General HospitalBoston, Massachusetts  02115