A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
Completed · Phase 1/Phase 2
Conditions studied: Transitional Cell Carcinoma of Bladder, Urethra Cancer, Ureter Cancer, Malignant Tumor of Renal Pelvis
In brief
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 in a biochemotherapy regimen either containing cisplatin and gemcitabine or containing gemcitabine alone in patients who have muscle invasive or metastatic urothelial cancer of bladder, renal pelvis, ureters and urethra. The purpose of this study is to evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended dose (RD), and assess the anti-tumor response of ALT-801 in combination with cisplatin and gemcitabine or ALT-801 in combination with gemcitabine alone. The pharmacokinetic profile of ALT-801 in combination with cisplatin and gemcitabine will also be assessed. The study includes a dose escalation phase (Phase Ib) and a dose expansion phase (Phase II). Phase II has two treatment groups, Expansion Group 1 and Expansion Group 2. Expansion Group 2 is for platinum-refractory patients, consisting of two treatment arms based on the patient's renal function. Patients will enroll to Expansion Group 2 after stage 1 of the Group 1 expansion is complete.
Key facts
- Study ID
- NCT01326871
- Run by
- Altor BioScience
- People needed
- 68
- Starts
- 2011-09-06
- Expected to finish
- 2016-04-11
- Last updated by the study team
- 2024-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The University of Arizona Cancer Center — Tucson, Arizona, United States
- UF Health Center at Orlando Health — Orlando, Florida, United States
- Martin Health System — Stuart, Florida, United States
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Robert Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of Kansas Cancer Center — Fairway, Kansas, United States
- Karmanos Cancer Center — Detroit, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Washington University — St Louis, Missouri, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- University of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
- St. Luke's Hospital and Health Network — Easton, Pennsylvania, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- UPMC Cancer Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.