A Phase 3 interventional study of larotaxel (XRP9881) and gemcitabine in Urinary Bladder Neoplasms, sponsored by Sanofi. Completed at 160 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-05.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 337 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Drug: larotaxel (XRP9881) · Drug: cisplatin
Drug: gemcitabine · Drug: cisplatin
administered on day 1 as a 1-hour infusion
administered on day 1, 8 and 15 as a 30-minute infusion
1 hour infusion administered on day 1, 30 minutes after the other treatment
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
Time frame: study period
Radiological tumor assessments (CT/MRI)
Time frame: at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression
Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status
Time frame: at screening and every cycle
Showing the first 100 of 160 sites across 19 countries.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi