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UM1 9947 Cisplatin/Gemcitabine +/- VX-970 in Metastatic Urothelial Carcinoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare any good and bad effects of using VX-970 along with the usual chemotherapy compared to usual chemotherapy alone.

What is the Condition Being Studied?

Bladder cancer that has spread beyond the bladder

Who Can Participate in the Study?

Adult patients with bladder cancer that has spread beyond the bladder who are planning to receive standard chemotherapy (cisplatin with gemcitabine).

Age Group
Adults

What is Involved?

If you join this study, after a screening period, you will be randomized (like the flip of a coin) to one of 2 groups:
-- standard chemotherapy (cisplatin with gemcitabine) alone
OR
-- standard chemo therapy plus VX-970.
-- You will receive treatment in 3 week cycles for up to 6 cycles.
-- You will have regular clinic visits and labs to see how you are tolerating the treatment.
-- You will also have imaging every 9 weeks to see whether your cancer is responding to the treatment.

Study Details

Full Title
A Randomized Phase 2 Trial of Cisplatin/Gemcitabine with or without VX-970 in Metastatic Urothelial Carcinoma
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00083963
NCT:NCT02567409
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698