Pazopanib for advanced and chemorefractory germ-cell tumors.

Phase II study of single-agent Pazopanib (Votrient) for patients with relapsed or refractory germ-cell tumors (GCT). - PAZOTEST-01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004910-33-IT

Enrollment

Registered

2012-12-11

Start date

2012-12-24

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Testicular or extragonadal germ cell tumors. MedDRA version: 14.1 Level: HLT Classification code 10018187 Term: Genitourinary neoplasms malignancy and gender unspecified System Organ Class: 100000004864

Interventions

Trade Name: VOTRIENT*FL 30CPR RIV 200MG Pharmaceutical Form: Tablet INN or Proposed INN: PAZOPANIB CAS Number: 444731-52-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Age > 18 years. - Eastern Cooperative Oncology Group (ECOG) Performance Status =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary end point(s): Safety and tolerability. Overall survival. Response rate.;Timepoint(s) of evaluation of this end point: 3 months	—

Countries

Italy

Contacts

Public ContactOncologia Medica 2

Fondazione IRCCS Istituto Nazionale dei Tumori

urologia@istitutotumori.mi.it02 2390 2402

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026