An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination with Ramucirumab (IMC 1121B) Drug Product or IMC 18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy
The purpose of this study is to evaluate the safety and effectiveness of Docetaxel in combination with Ramucirumab (IMC-1121B) drug product or IMC-18F1 or without Investigational therapy as second-line therapy in patients with locally advanced or metastatic transitional cell cancer of the bladder, urethra, ureter, or renal pelvis following progression of disease on first-line platinum-based therapy.
The patient must have confirmed diagnosis of transitional cell cancer of the bladder, urethra, ureter, or renal pelvis, and must have progression of disease while on a platinum-containing regimen or within 12 months after the last dose of therapy in the locally advanced or metastatic setting. The patient can not have received more than 2 prior systemic chemotherapy regimens in any setting. Must have adequate bone marrow production, and good kidney and liver functions. Cannot have a history of uncontrolled hereditary or acquired bleeding or clotting disorders. No brain metastasis, no active diverticulitis. No history of chronic diarrhea or an acute/subacute bowel obstruction. Cannot be pregnant.
The patients will be randomized in a 1:1 ratio to 1 of 3 treatment arms: docetaxel alone on Day 1 of each 21 day cycle (Arm A); docetaxel on Day 1 and Ramucirumab DP on Day 1 (+/- 3 days) of each 21 day cycle (Arm B); or docetaxel on Day 1 and IMC-18F1 on Day 1 (+/- 3 days) and Day 8 (+3 days) of each 21 Day cycle (Arm C).
03/07/2014 04:02 AM