Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) (NCT04631744) | Clinical Trial Compass
TerminatedPhase 2
Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Stopped: Low accrual
United States4 participantsStarted 2021-03-03
Plain-language summary
The purpose of this study is to determine what effects (good and bad) cabozantinib has in treatment of patients with metastatic castrate resistant prostate cancer (mCRPC).
The hypothesis for this trial is that cabozantinib has anti-tumor activity in a molecularly-selected group of patients with CRPC or patients with liver metastases.
Who can participate
Age range18 Years – 99 Years
SexMALE
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Inclusion criteria
✓. Age \>18 years.
✓. Documented histological or cytological diagnosis of prostate carcinoma.
✓. Evidence of metastatic PC on imaging (bone scan and/or CT/MRI scan)
✓. Agree to undergo a biopsy of at least one metastatic site or primary prostate prior to beginning therapy. Adequate archival metastatic tissue can be used if available in lieu of a biopsy if done when patient had CRPC and within 6 months of the start of treatment.
✓. Agree to undergo a biopsy of at least one metastatic site or primary prostate after 3 weeks of therapy (biopsy must be between day 21 and day 24 of treatment). Re-biopsy of same pre-treatment biopsy soft tissue site especially liver metastases is preferred.
✓. Serum testosterone level less than 50 ng/dl. Subjects without prior orchiectomy must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) therapy until permanent discontinuation of study treatment.
✓. Documented progressive metastatic CRPC based on at least one of the following criteria:
✓. ECOG performance status of 0-1
Exclusion criteria
✕. Prior treatment with cabozantinib
✕. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
✕
What they're measuring
1
Median Radiographic Progression-free Survival (rPFS) Using Kaplan-Meier Methodology
Timeframe: From initiation of treatment to minimum of radiographic progression, approximately 6 months.
Trial details
NCT IDNCT04631744
SponsorWeill Medical College of Cornell University
. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) except agents to maintain castrate status within 4 weeks before first dose of study treatment. Antiresportive bone agents are also allowed.
✕. Subject has received abiraterone acetate or enzalutamide within 2 weeks before enrollment.
✕. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
✕. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment for neurological indications at the time of first dose of study treatment.
✕. Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
✕. The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 14 days before the first dose of study treatment.