Study S001480

A Phase Ib/II Trial of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT01326871
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1; PHASE2
Masking: NONE
Status: COMPLETED
Enrollment: 68
Start: 2011-09-06
Primary completion: 2016-04-11
Lead sponsor: Altor BioScience
Conditions: Transitional Cell Carcinoma of Bladder; Urethra Cancer; Ureter Cancer; Malignant Tumor of Renal Pelvis
Interventions: DRUG:Cisplatin; DRUG:Gemcitabine; BIOLOGICAL:ALT-801
Results posted: TRUE

Registered primary outcomes

Maximum Tolerated Dose (MTD) and/or the Recommended Dose (RD) for Dose Expansion of ALT-801 in Combination With Cisplatin and Gemcitabine or ALT-801 in Combination With Gemcitabine Alone [8 weeks]
Number of Participants With Adverse Events [8 weeks]
Objective Response Rate in Treated Patients [12 weeks]

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