Clinical trial · Interventional
Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer
Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This is similar to how several other cancer drugs work but in addition Cabozantinib also blocks other pathways that may be responsible for allowing cancer cells to become resistant to these other "anti-angiogenic" treatments. So far cabozantinib has been investigated in treating brain cancer and a rare form of thyroid cancer. This study will explore lower doses of cabozantinib with the goal to find the most effective, safe, and tolerable dose without undesirable side effects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cabozantinib | Drug | Cabozantinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Dose level 0: cabozantinib 40 mg daily
- interventionNames
- Drug: cabozantinib
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Dose level -1: cabozantinib 20 mg daily
- interventionNames
- Drug: cabozantinib
- type
- EXPERIMENTAL
- label
- Expansion cohort
- description
- Dose level 0: cabozantinib 40 mg daily
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * Bone metastases confirmed by bone scan * Current androgen deprivation therapy * Castration-resistant disease based on progression in bone and/or PSA progression * Recovered from toxicities related to prior treatment, except alopecia, lymphopenia, other non-clinically significant adverse events * Life expectancy of greater than 3 months * Normal organ and marrow function * Capable of understanding and complying with the protocol requirements * Agree to use medically accepted methods of contraception * Able to swallow capsules Exclusion Criteria: * More than two prior chemotherapy regimens for metastatic prostate cancer * Known untreated, symptomatic or uncontrolled brain metastases * Serious or unhealed wound * Treatment with anticoagulants * Previously identified allergy or hypersensitivity to components of the study treatment formulation * History of a different malignancy unless disease-free for at least 5 years, or basal or squamous cell carcinoma of the skin * Current antiretroviral therapy * Uncontrolled hypertension * Uncontrolled intercurrent illness
References
Publications (1)
- RESULTLee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR. A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases. Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3. PMID 23553848