Phase 2
N=17
A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01834651 ↗Enrolled (actual)
17
Serious AEs
82.4%
Results posted
Sep 2017
Primary outcome: Primary: Clinical Benefit Rate From Cabozantinib (XL184) — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cabozantinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Edwin Posadas, MD
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate From Cabozantinib (XL184) |
10 | — |
| SECONDARY Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib |
53.2 | — |
| SECONDARY Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells |
16 | — |
| SECONDARY Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration |
-322.96; 191.1 | — |
| SECONDARY Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) |
4; 2; 1; 1; 1; 1 | — |
| SECONDARY Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death |
12 | — |
Summary
This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.
Eligibility Criteria
KEY INCLUSION CRITERIA
- mCRPC that includes visceral disease. Visceral metastatic disease is defined as solid organ infiltration that is not bone or lymph node metastases.
KEY EXCLUSION CRITERIA
- Recent history (<6 months) of gastrointestinal hemorrhage requiring blood transfusion.
- Tumor involvement in the intestinal lining which the treating physician deems at risk for perforation with rapid tumor response.
Data sourced from ClinicalTrials.gov (NCT01834651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.