Phase I Study With Sorafenib in Addition to Vinflunine in Metastatic Transitional Cell Carcinoma of the Urothelial Tract (VINSOR)
Renal Pelvis Cancer
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Exploratory Phase I Study With Sorafenib in Addition to Vinflunine in Progressive Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract|
- Number of patients with adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Define the recommended phase II dose (RPTD) by the number of dose limiting toxicity events (recorded during treatment cycle 1 and 2)
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: vinflunine + sorafenib
Single arm study.
Vinflunine (Javlor®, Pierre Fabre Pharma): 320 mg/m2 I.V., day 1, repeated every 21 days for patients with PS 0, adequate renal (creatinine clearance >60 ml/min) and hepatic function (as described in the inclusion criteria). PLEASE NOTE THAT THE 320 mg/m2 ARM IS CLOSED FOR RECRUITMENT.
For patients with PS 1, or age 75 to 80 years, or exposed to radiation of the lower pelvis region, or with impaired renal function (creatinine clearance 40-60 ml/min) but adequate hepatic function (as described in the inclusion criteria), the dose of vinflunine is 280 mg/m2 I.V. day 1, repeated every 21 days.
Other Name: JavlorDrug: Sorafenib
Sorafenib (Nexavar®, Bayer HealthCare) daily dosage from day 2 through day 21 (repeated every 21 days):
Step 1: 400 mg P.O. (i.e. one (1) tablet 200 mg morning and evening, 1+0+1) Step 2: 600 P.O. (i.e. one (1) tablet 200 mg morning and two tablets evening, 1+0+2) Step 3: 800 mg P.O. (i.e. two (2) tablets 200 mg morning and evening, 2+0+2) Doses of sorafenib higher than 400 mg P.O. b.i.d. are not allowed.
Other Name: Nexavar
- To explore the safety of sorafenib in combination with vinflunine in patients with transitional cell carcinoma of the urothelial tract and to define a recommended phase II dose for this treatment combination
- To correlate early tracer 18F-FDG-PET/CT functional imaging readouts with standard RECIST (version 1.1) evaluations with the intention to explore new endpoints for targeted therapy
- To find predictive tumour tissue biomarkers for sorafenib/vinflunine treatment
- To evaluate serum and urine markers of apoptosis as potential markers of sorafenib/vinflunine treatment
To evaluate the tolerability and activity of sorafenib combined with vinflunine in patients with advanced or metastatic urothelial cancer.
Tumour biopsies will be collected before and after one cycle of therapy. The translational part of this study aims to explore the predictive value of a number of biomarkers related to the targeted properties of sorafenib and presumptive markers for vinflunine treatment.
In addition, the predictive value of an early functional imaging tracer 18F-FDG-PET/CT will be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01844947
|Contact: Anders Ullén, M.D., Ph.D.||+46-8-517 70 email@example.com|
|Contact: Carl-Henrik Shah, M.D.||+46-8-517 70 000 ext firstname.lastname@example.org|
|Department of Oncology, Aarhus University Hospital||Active, not recruiting|
|Aarhus, Denmark, DK-8200|
|Department of Oncology, Rigshospitalet||Active, not recruiting|
|Copenhagen, Denmark, DK-2100|
|Department of Oncology, Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, SE-171 76|
|Contact: Anders Ullén, M.D., Ph.D. +46-8-517 70 000 email@example.com|
|Contact: Carl-Henrik Shah, M.D. +46-8-517 70 000 ext 91425 firstname.lastname@example.org|
|Principal Investigator: Anders Ullén, M.D., Ph.D.|
|Sub-Investigator: Carl-Henrik Shah, M.D.|
|Sub-Investigator: Karin Holmsten, M.D.|
|Principal Investigator:||Anders Ullén, M.D., Ph.D.||Dept of Oncology, Karolinska University Hospital|