Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

NCT01812668 | Completed Results DMC

• 2 other identifiers: 2011-185NCI-2013-00399
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in PET Standard Uptake Value SUV Levels Pre-treatment to Post-treatment.

  Change in PET standard uptake value SUV levels (each value measured in g/ml). (post-treatment - pre-treatment)/pre-treatment x 100 , therefore, measured in percentage change from baseline.

  Baseline to 4 weeks

Secondary Outcomes (5)

• Time to Progression

  From date of registration to date of first documented disease progression, or death from any cause, assessed up to 1 year

• Number of Participants With Indicated Toxicities Grade 3 or Higher

  Up to 4 weeks post-treatment, about 2 years on average.

• Number of Participants With Indicated Clinical Response Based on the RECIST Criteria 1.1

  Up to 1 year

• PSA Response Based on the RECIST Criteria 1.1

  Up to 1 year

• PET Response Based on the RECIST Criteria 1.1

  Up to 1 year

Study Arms (1)

Treatment (cabozantinib-s-malate)

EXPERIMENTAL

Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.

Drug: cabozantinib-s-malate; Radiation: fluorine F 18 d-FMAU; Procedure: positron emission tomography; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

cabozantinib-s-malate DRUG

Given PO

Also known as: BMS-907351, Cometriq, XL184

Treatment (cabozantinib-s-malate)

fluorine F 18 d-FMAU RADIATION

Undergo 18F PET/FMAU PET scan

Treatment (cabozantinib-s-malate)

positron emission tomography PROCEDURE

Undergo 18F PET/FMAU PET scan

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Treatment (cabozantinib-s-malate)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (cabozantinib-s-malate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (cabozantinib-s-malate)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has histologically confirmed prostate adenocarcinoma with radiologic evidence of metastases
• If patient are on anti-androgens, these should be discontinued, at least 4 weeks prior for flutamide and at least 6 weeks for bicalutamide or nilutamide
• At least 14 days should have elapsed from prior radiation therapy to bone metastases from prostate cancer
• The patient has received a maximum of one prior chemotherapy regimen for metastatic prostate cancer
• Patients must demonstrate disease progression on or after most recent systemic therapy, either by prostate-specific antigen (PSA), new bone metastases or by measurable disease criteria per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
• Patients should have received either luteinizing hormone-releasing hormone (LHRH) analogue, or LHRH analogue and anti- androgen for metastatic prostate cancer
• The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Bisphosphonate therapy can be continued if started prior to protocol enrollment
• Patients must have blood pressure (BP) readings \< 150/90 prior to enrollment
• Absolute neutrophil count (ANC) \>= 1500/mm\^3 without colony stimulating factor support
• Platelets \>= 100,000/mm\^3
• Hemoglobin \>= 9 g/dL
• Bilirubin =\< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert's disease, bilirubin =\< 3.0 mg/dL
• Serum albumin \>= 2.8 g/dl
• Serum creatinine =\< 1.5 x ULN or creatinine clearance (CrCl) \>= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used

You may not qualify if:

• 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
• Prior treatment with cabozantinib
• The subject has received radiation therapy:
• To the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment
• To bone or brain metastasis within 14 days of the first dose of study treatment
• To any other site(s) within 28 days of the first dose of study treatment
• The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
• The subject has received 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, before the first dose of study treatment; patients receiving LHRH or gonadotropin-releasing hormone (GnRH) agonists to maintain castrate levels of testosterone or patients on bisphosphonate/denosumab, may be maintained on these agents
• The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
• The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =\< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
• The subject has a primary brain tumor
• The subject has active brain metastases or epidural disease (Note: Subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain scans are not required to confirm eligibility)
• The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening \>= 1.3 x the laboratory ULN
• The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor xabans (Xa) inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=\< 81 mg/day), low-dose warfarin (=\< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
• The subject has experienced any of the following within 3 months before the first dose of study treatment:

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabozantinib; clevudine; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Elisabeth Heath
• Organization: Barbara Ann Karmanos Cancer Institute

heathe@karmanos.org

313-576-8734

Study Officials

• Ulka Vaishampayan

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 18, 2013
• Study Start: March 1, 2013
• Primary Completion: January 18, 2019
• Study Completion: June 18, 2019
• Last Updated: August 5, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-08

Locations

US (1)