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A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases

Cabozantinib (XL184), a multi-targeted tyrosine kinase inhibitor, has demonstrated a
powerful clinical phenotype in men with metastatic castrate resistant prostate cancer
(mCRPC) both before and after chemotherapy. This phenotype consists of rapid reduction in
pain (when present) and improvement in bone scans that may or may not be accompanied by
decrease in serum prostate specific antigen (PSA) concentrations. In previous studies of
cabozantinib in advanced prostate cancer, patients with visceral disease have been excluded.
Hence, this protocol creates a unique opportunity to define the activity of this disease in
the population of men with visceral disease - a marker for poorer prognosis in mCRPC.

Primary Objectives:

- To assess the clinical benefit (complete response + partial response + stable disease) of
cabozantinib in patients with mCRPC with visceral metastases.

Secondary Objectives:

- To assess the impact of cabozantinib on numbers live circulating tumor cells (CTCs)
using a novel combination of nanofluidic technology and near-infrared heptamethine
cyanine dyes.

- To test the feasibility of measuring variation in gene expression in circulating tumor
cells (CTCs) in response to therapy.

- To determine if there is an impact of cabozantinib on live circulating tumor cell (CTC)
number and patterns of gene expression.

- To measure the impact of cabozantinib on serum HGF (hepatocyte growth factor) and VEGF
(vascular endothelial growth factor) levels in men with metastatic,
castration-resistant prostate cancer (mCRPC).

- To assess the safety and tolerability of lower doses (i.e. doses below 100 mg daily) of
cabozantinib in mCRPC with visceral metastases.

- To collect biospecimens which may be used determine if there are germline genetic
variations that correlate with toxicity.

- To pilot correlations between molecular content between circulating tumor cells (CTCs),
large oncosomes, and tumor tissue.

Inclusion Criteria


- mCRPC that includes visceral disease. Visceral metastatic disease is defined as solid
organ infiltration that is not bone or lymph node metastases.


- Recent history (<6 months) of gastrointestinal hemorrhage requiring blood

- Tumor involvement in the intestinal lining which the treating physician deems at risk
for perforation with rapid tumor response.

Type of Study:


Study Design:

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

Outcome Measure:

Clinical benefit rate from cabozantinib (XL184)

Outcome Description:

Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria.

Outcome Time Frame:

Baseline to 12 weeks after starting therapy

Safety Issue:


Principal Investigator

Edwin Posadas, MD FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

April 2018

Related Keywords:

  • Prostate Cancer
  • liver metastasis
  • lung metastasis
  • metastatic castrate-resistant
  • prostate cancer
  • Neoplasm Metastasis
  • Prostatic Neoplasms



Cedars-Sinai Medical CenterLos Angeles, California  90048