Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

Phase 2

Completed

• Conditions: Germ Cell Tumors; Measurable Disease
• Interventions: Drug: Pazopanib

• Registration Number: NCT01743482
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Study Start: 2013-05-17
• Primary Completion: 2016-07-27
• Study Completion: 2016-07-27
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

• Male gender.
• Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.
• Unequivocal progression of measurable disease.
• A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.
• First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.
• Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.

Exclusion Criteria

• Failure to meet any of the above inclusion criteria.
• Concurrent treatment with other cytotoxic drugs or targeted therapies.
• Prior radiation therapy within 14 days of trial start.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pazopanib	Pazopanib	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	3-months	To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.

Secondary Outcome Measures

Name	Time	Method
Response Rate	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
Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03	3 months
Overall survival (OS)	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.

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Mi, Italy