Gemcitabine and Split-Dose Cisplatin Plus Everolimus (RAD001) in Patients With Advanced Solid Tumor Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Bladder CancerRenal Pelvis CancerUreter Cancer
Interventions
DRUG

gemcitabine and split-dose cisplatin plus escalating doses of continuous Everolimus (RAD001)

Patients will receive gemcitabine IV and cisplatin IV on days 1 and 8. Everolimus orally will be administered continuously (one cycle = 21 days). Everolimus will be escalated at the following dose levels: 5mg every-other-day, 5mg daily, and 10mg daily. Patients will receive a total of 6 cycles of gemcitabine and cisplatin in combination with Everolimus unless disease progression or unacceptable toxicity occurs.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER