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Cabozantinib in Men With Castration-Resistant Prostate Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Cabozantinib in Men With Castration-Resistant Prostate Cancer

A Pilot Study of the Effects of Cabozantinib (XL184) on Bone Turnover and the Microenvironment in Men With Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer

NCT01703065•University of Washington

View on ClinicalTrials.gov

Summary

This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description

Primary Outcome Measure: 1. Change in urinary N-telopeptide (uNTX) from baseline to after 6 weeks of treatment with cabozantinib in men with non-metastatic CRPC. Secondary Outcome Measures: 2. Changes in serum markers of bone metabolism from baseline to after 6 weeks of treatment with cabozantinib. Markers of bone metabolism in blood include bone specific alkaline phosphatase, alkaline phosphatase, LDH. 3. Changes in biomarker expression in bone biopsy samples. To include MET, AKT, FASN and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells. Will also include changes in markers of apoptosis, proliferation, and angiogenesis. OUTLINE: Patients receive cabozantinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. The subject has a proven histologic diagnosis of prostate adenocarcinoma, but may have undergone prior surgery and/or radiation.
•2. The subject must currently have castration resistant prostate cancer defined as 2 serial rising PSAs with a castrate level of testosterone (\<50 ng/dL).
•3. A subject with non-metastatic CRPC may not have received prior chemotherapy unless in the neoadjuvant or adjuvant setting \> 24 months ago and may not have received prior zoledronic acid or denosumab.
•4. A subject with metastatic CRPC must have bone metastases accessible for biopsy by CT guidance.
•5. The subject must be willing to undergo sequential biopsy of bone or bone metastases.
•6. Subjects must have discontinued additional hormonal (eg bicalutamide, abiraterone, estrogen) therapy prior to the first dose of cabozantinib. No antiandrogen withdrawal period is required.
•7. Subjects previously treated on another investigational agent must have a 2-week or more washout before starting cabozantinib, depending on the agent, toxicity profile, and half-life. However, such patients may begin tetracycline dosing after consent is signed.
•8. Subjects who are currently on GnRH agonists or antagonist therapy must continue androgen suppression.
•9. The subject is ≥18 years old on day of consent.
•10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
+14 more criteria

Exclusion Criteria

•1. The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas/ mitomycin C within 6 weeks before the first dose of study treatment.
•2. Prior treatment with cabozantinib and other met inhibitors.
•3. Prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 14 days or five half-lives of the compound or active metabolites, whichever is longer, or before the first dose of study treatment.
•4. The subject has received radiation therapy:
•1. to the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment.
•2. to bone or brain metastasis within 14 days of the first dose of study treatment.
•3. to any other site(s) within 28 days of the first dose of study treatment.
•5. The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment.
•6. The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
•7. The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs.
+38 more criteria

Locations (1)

Seattle Cancer Care Alliance/University of Washington

Seattle, Washington, United States

Key Dates

Start Date

June 18, 2013

Primary Completion Date

February 2, 2015

Completion Date

September 18, 2015

Last Updated

December 4, 2018

Enrollment

ACTUAL participants

Conditions

Adenocarcinoma of the ProstateCastration-resistant Prostate CancerRecurrent Prostate CancerStage III Prostate CancerStage IV Prostate Cancer

Interventions

Cabozantinib

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cabozantinib in Men With Castration-Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer