Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors (Pazotest-01)
This is an open label, single arm, single center, phase 2 study with the use of the antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell tumors who are not cured following first or subsequent chemotherapy lines for metastatic disease, followed by eventual surgery.
Germ Cell Tumors
Relapse or Progression After 2 or 3 Chemotherapy Regimens.
Relapse or Progression After High-dose Chemotherapy.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).|
- Progression Free Survival [ Time Frame: 3-months ] [ Designated as safety issue: No ]To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.
- Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Response Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]A response rate will be considered as the sum of complete (CR) and partial responses (PR) according to the response evaluation criteria in solid tumors (RECIST), version 1.1
- Overall survival (OS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]OS time will be calculated as the interval from treatment start date to the date of death for any cause, with censoring at the date of last contact for patients alive. The Kaplan-Meier method will be used to estimate the OS curve.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Patients will receive pazopanib at the dose of 800 mg/day orally until disease progression or evidence of unacceptable toxicity/side effects. The study will be performed according to Simon's two-stage optimal design.
Other Name: Votrient
|Contact: Andrea Necchi, MDemail@example.com|
|Fondazione IRCCS Istituto Nazionale dei Tumori||Not yet recruiting|
|Milano, Mi, Italy, 20133|
|Contact: Andrea Necchi, MD +39 02 2390 2402 firstname.lastname@example.org|
|Sub-Investigator: Patrizia Giannatempo, MD|
|Principal Investigator: Andrea Necchi, MD|