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A Phase II Trial of Cabozantinib (XL184) in Patients With Castrate-Resistant Prostate Cancer Metastatic to Bone

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer Metastatic

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Trial Information

A Phase II Trial of Cabozantinib (XL184) in Patients With Castrate-Resistant Prostate Cancer Metastatic to Bone

A significant proportion of patients with prostate cancer develop metastatic disease, which
most commonly affects the skeleton. Bone metastases are the cause of significant morbidity
and mortality in these patients, and require long-term management. Study participants in
this research study will have a diagnosis of castration-resistant prostate cancer metastatic
to bone.

Cabozantinib is not approved by the United States Food and Drug Administration (FDA) to
treat people for castration-resistant prostate cancer metastatic to bone or for any other
type of cancer. Giving cabozantinib to human cancer patients is experimental. Cabozantinib
is currently being given to patients on other studies. Cabozantinib is known to have
anti-tumor effects and to reduce bone metastases based on early clinical studies in prostate
cancer and other cancers. The drug is known to have side effects. The most common side
effects were fatigue, diarrhea, anorexia, rash, and palmar-plantar erythrodysesthesia (PPE)
syndrome. To date, it is not known if cabozantinib is safe and/or effective.

Inclusion Criteria:

- Pathologically and radiologically confirmed castrate-resistant prostate cancer
metastatic to bone

- Bone metastases which are accessible for biopsy under CT guidance.

- Willingness to undergo sequential biopsy of bone lesions.

- No prior standard chemotherapy for metastatic disease (neoadjuvant, adjuvant and
hormonal treatments are excluded).

- Participant must have discontinued antiandrogen therapy at least 4 weeks (for
flutamide and megestrol acetate) or 6 weeks (for bicalutamide or nilutamide) prior to
the first dose of XL184. Participants currently on LHRH or GnRH agonists can be
maintained on these agents.

- Greater than or equal to 18 years old on day of consent

- Participants must be able to care for themselves

- Adequate organ and bone marrow function

- Participants must be capable of understanding and complying with the protocol
requirements and has signed the informed consent document.

- Men capable of sexual activity will be required to agree to use a condom during
sexual contact with women having the potential to bear children during their
participation in the study and for six months after participation.

Exclusion Criteria:

- Prior therapy with cabozantinib

- Any other type of investigational agent within 28 days before the first dose of study
treatment or 5 half-lives of the compound or active metabolite, whichever is longer

- No radiation therapy within 14 days of study treatment. No radionuclide treatment
within two months.

- No known brain metastases.

- Test results that measure how quickly blood clots need to be adequate for the study

- Participants who require concomitant treatment, in therapeutic doses, with
anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or
Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel). Low dose aspirin (≤
81 mg/day), low-dose warfarin (≤ 1 mg/day), and prophylactic low molecular weight
heparin (LMWH) are permitted.

- Participants must not have uncontrolled significant illness including but not limited
to: ongoing or active infection requiring systemic treatment, symptomatic congestive
heart failure, uncontrolled hypertension , history of hypertensive emergency
(e.g.encephalopathy) or hypertensive urgency within 6 months of study treatment,
clinically significant wounds including osteonecrosis, history of organ transplant,
unstable angina pectoris, stroke within 3 months of study drug, heart attack within 3
months of study drug, development of clots within blood vessels within 6 months of
study drug, bleeding from distended veins within 3 months of study drug, any other
severe or life threatening hemorrhage/bleeding, major surgery within 4 weeks of study
treatment, clinically significant cardiac arrhythmias, history of bowel obstruction
or malabsorption syndrome, untreated bone fracture including tumor-related pathologic
fracture, anticipated need for major surgery during the period of the study.

- Corrected QT interval, as measured by an ECG, must be within acceptable protocol
limits within 28 days of entering the study

- Unable to swallow capsules

- Allergy to doxycycline or other tetracyclines

- Unable to undergo MRI

- History of another malignant disease within two years with the exception of
superficial skin or bladder cancer which has been completely resected or carcinoma in
situ without evidence of invasion.

Type of Study:


Study Design:

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

Outcome Measure:

Efficacy of cabozantinib in patients with castrate-resistant prostate cancer metastatic to bone.

Outcome Description:

Efficacy will be measured by the proportion of participants who remain progression-free at 12 weeks after initiation of the study.

Outcome Time Frame:

12 weeks after participant initiates study

Safety Issue:


Principal Investigator

David C. Smith, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Food and Drug Administration

Study ID:

UMCC 2011.069



Start Date:

February 2012

Completion Date:

November 2015

Related Keywords:

  • Prostate Cancer Metastatic
  • Prostate
  • Cancer
  • Metastatic
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



University of Michigan Ann Arbor, Michigan  48109-0624