Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

NCT01743482 | Completed Phase 2 DMC

• 1 other identifier: INT123/12
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Germ Cell Tumors; Measurable Disease

Keywords

Testicular Cancer; Germ Cell Tumors; Salvage Therapy; Pazopanib

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.

  3-months

Secondary Outcomes (3)

• Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03

  3 months

• Response Rate

  3 months

• Overall survival (OS)

  6 months

Study Arms (1)

Pazopanib

EXPERIMENTAL

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.

Drug: Pazopanib

Interventions

Pazopanib DRUG

Also known as: Votrient

Pazopanib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Concurrent treatment with other cytotoxic drugs or targeted therapies.
• Prior radiation therapy within 14 days of trial start.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Mi, 20133, Italy

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty, Department of Medical Oncology

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 6, 2012
• Study Start: May 17, 2013
• Primary Completion: July 27, 2016
• Study Completion: July 27, 2016
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

IT (1)