Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

Conditions

Germ Cell Tumors, Measurable Disease

Keywords

Testicular Cancer, Germ Cell Tumors, Salvage Therapy, Pazopanib

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.

Necchi A, Lo Vullo S, Giannatempo P, Raggi D, Calareso G, Togliardi E, Crippa F, Pennati M, Zaffaroni N, Perrone F, Busico A, Colecchia M, Nicolai N, Mariani L, Salvioni R.

2017-06-0128 citations

10.1093/annonc/mdx124

Pazopanib (PZP) in germ cell tumors (GCT) after chemotherapy (CT) failure: Final results of the open label, single-group, phase II Pazotest trial.

Andrea Necchi, Salvatore Lo Vullo, Patrizia Giannatempo, Daniele Raggi, Giuseppina Calareso et al. (14 authors)

Journal of Clinical Oncology2017-02-201 citations

10.1200/jco.2017.35.6_suppl.414

Pazopanib in patients (pts) with advanced germ cell tumors (GCT): Results from an open-label, single-group, phase 2 trial (Pazotest-01).

Andrea Necchi, Daniele Raggi, Patrizia Giannatempo, Giuseppina Calareso, E. Togliardi et al. (9 authors)

Journal of Clinical Oncology2016-01-101 citations

10.1200/jco.2016.34.2_suppl.481

Pazopanib in chemoresistant patients with germ cell tumors (GCT): Updated results of the open-label, single-group, phase 2 Pazotest-01 trial.

Patrizia Giannatempo, Luigi Mariani, Nicola Nicolai, Elena Farè, Daniele Raggi et al. (17 authors)

Journal of Clinical Oncology2014-05-201 citations

10.1200/jco.2014.32.15_suppl.e15529

Activity of pazopanib in chemo-resistant patients with germ cell tumors (GCT): First results of the open-label, single-group, phase II PAZOTEST-01 trial.

Patrizia Giannatempo, Nicola Nicolai, Elena Farè, Daniele Raggi, Luigi Piva et al. (15 authors)

Journal of Clinical Oncology2014-02-016 citations

10.1200/jco.2014.32.4_suppl.376

Interventions

DRUGPazopanib

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

Healthy volunteers

No

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03	3 months	—
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
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.

Countries

Italy

Outcome results

None listed