Pazopanib for advanced and chemorefractory germ-cell tumors.

Phase 1

Conditions: Testicular or extragonadal germ cell tumors.
MedDRA version: 14.1Level: HLTClassification code 10018187Term: Genitourinary neoplasms malignancy and gender unspecifiedSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2012-004910-33-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 43

Inclusion Criteria

- Age > 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
- A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease (enrollment will take place either as 3rd or 4th line of treatment), EXCEPT FOR primary mediastinal nonseminomas, to which the 2nd line setting will apply.
- 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.
- Adequate hematopoietic and organ function.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Significant comorbidities that preclude the administration of Pazopanib.
2.Severe ongoing infections, grade > 2 of the CTCAE v.4.03..
4. Patients with late-relapse (defined as relapse occurring after at least 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are ineligible. In general, these patients are recommended for initial surgical extirpation rather than chemotherapy or other drugs. Patients with late relapse who have either unresectable disease or highly elevated markers will be eligible.
5. More than 3 prior chemotherapy regimens.
6. Prior cancer except for basal cell carcinoma and any other cancer that has been cured since 5 years before.
7. Any medical and psychiatric conditions that could jeopardize the observation of protocol procedures.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the activity of Pazopanib in a population of patients with pre-treated germ cell tumors.<br>Primary endpoint: 3-month progression-free survival;Secondary Objective: Overall survival.<br>Response-rate.<br>Safety and tolerability.;Primary end point(s): 3-month PFS;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures