Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors (Pazotest-01)
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|ClinicalTrials.gov Identifier: NCT01743482|
Recruitment Status : Unknown
Verified December 2012 by Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was: Not yet recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Germ Cell Tumors Measurable Disease Relapse or Progression After 2 or 3 Chemotherapy Regimens. Relapse or Progression After High-dose Chemotherapy.||Drug: Pazopanib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||April 2015|
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
- Progression Free Survival [ Time Frame: 3-months ]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 ]
- Response Rate [ Time Frame: 3 months ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743482
|Contact: Andrea Necchi, MDfirstname.lastname@example.org|
|Fondazione IRCCS Istituto Nazionale dei Tumori|
|Milano, Mi, Italy, 20133|
|Contact: Andrea Necchi, MD +39 02 2390 2402 email@example.com|
|Sub-Investigator: Patrizia Giannatempo, MD|
|Principal Investigator: Andrea Necchi, MD|