A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of Ramucirumab plus Docetaxel Versus Placebo plus Docetaxel in Patients with Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy

INTERVENTION: investigational material(s) Generic name etc : Ramucirumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : ramucirumab (10 mg/kg) intravenously (I.V.) plus docetaxel (75 mg/m2) I.V. CONDITION: Urothelial Carcinoma PRIMARY OUTCOME: Progression‐free survival (PFS) SECONDARY OUTCOME: overall survival time; objective response rate; disease control rate; duration of response; European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐C30 [EORTC QLQ‐C30] and EQ 5D‐5L questionnaires; the pharmacokinetic profile of ramucirumab; the immunogenicity of ramucirumab INCLUSION CRITERIA: [1]The patient has histologically or cytologically confirmed, locally advanced or unresectable or metastatic urothelial (transitional cell) carcinoma of the bladder, urethra, ureter, or renal pelvis. [2]The patient has demonstrated disease progression while on a platinum‐containing regimen in the first‐line setting or within 14 months (more than 14 months) after completing the first line platinum regimen. [3]The patient has a life expectancy of 3 months, in the judgment of the investigator. [4]The patient has received no more than one prior systemic chemotherapy regimen in the relapsed or metastatic setting. [5]The patient has measurable disease or nonmeasurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) [6]The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. [7]The patient has not received blood or blood components transfusion within 2 weeks.

Epistemonikos ID: 9c505e96f833d04b1c6f5f0a4c8426d1b631593f
First added on: Aug 26, 2024