Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma. (CabUC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04066595|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Drug: Cabozantinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||2 cohorts. Cohort 1 will consist of patients who have been pre-treated with checkpoint inhibitors only (2nd line setting for cabozantinib). Cohort 2 will consist of patients who have been pre-treated with cisplatin-based chemotherapy and checkpoint inhibitors (3rd line setting for cabozantinib).|
|Masking:||None (Open Label)|
|Official Title:||Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Progressed After Cisplatin-based Chemotherapy and Anti-PD-1/PD-L1 Therapy or After Anti-PD-1/PD-L1 Therapy Only.|
|Actual Study Start Date :||February 10, 2020|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Experimental (cohorts 1 and 2)
Cohort 1 will consist of patients who have been pre-treated with checkpoint inhibitors only (2nd line setting for cabozantinib). Cohort 2 will consist of patients who have been pre-treated with cisplatin-based chemotherapy and checkpoint inhibitors (3rd line setting for cabozantinib). Both cohorts receive the same treatment.
60 mg cabozantinib oral daily. When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.
Other Name: Cabometyx
- Objective response rate after 6 months of cabozantinib treatment [ Time Frame: 6 months ]The response rate is defined as the percentage of subjects with a confirmed reduction in tumor size compared to baseline as well as fulfilling the criteria for complete or partial response according to RECIST 1.1. The response to treatment is measured by computer tomography (CT) every 12 weeks starting from the first day of cabozantinib treatment.
- Progression-free survival (PFS) [ Time Frame: Through study completion, up to approximately 2 years ]PFS is defined as the time from first intake of trial medication to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm.
- 1-year survival [ Time Frame: 1 year ]Rate of subjects surviving for at least one year after first intake/dose of trial medication
- Overall survival [ Time Frame: Through study completion, up to approximately 2 years ]The time between first application of trial medication to date of death due to any cause
- Clinical benefit rate [ Time Frame: Through study completion, up to approximately 2 years ]Complete or partial response or stable disease for ≥ 6 months according to RECIST 1.1
- Response duration [ Time Frame: Through study completion, up to approximately 2 years ]Duration of response in months from the first response (CR or PR) to progress after first intake of treatment medication
- Number of Participants with Adverse Events (AEs) [ Time Frame: Through study completion, up to approximately 2 years ]An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
- Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs) [ Time Frame: Through study completion, up to approximately 2 years ]The number of participants who discontinue study treatment due to an AE will be presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066595
|Contact: Georg Bartsch, MD, Prof.||+firstname.lastname@example.org|
|Department of Urology of the University Medical Center Mainz||Recruiting|
|Mainz, Germany, 55131|
|Contact: Regina Loebbecke email@example.com|