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Brentuximab Vedotin (SGN-35) as Salvage Therapy for Males With Advanced and Platinum-resistant Germ-cell Tumors. An Open Label, Single Group, Phase 2 Trial.


Phase 2
18 Years
N/A
Not Enrolling
Male
Germ Cell Cancer

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Trial Information

Brentuximab Vedotin (SGN-35) as Salvage Therapy for Males With Advanced and Platinum-resistant Germ-cell Tumors. An Open Label, Single Group, Phase 2 Trial.


Inclusion Criteria:



- Age of at least 18 years.

- Confirmation of germ cell tumor histology based on pathologic review at the study
site.

- Presence of a CD30 positive embryonal carcinoma component.

- Unequivocal progression of measurable disease.

- A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic
disease EXCEPT for primary mediastinal germ cell tumors where failure of first-line
chemotherapy only is accepted.

- Prior high dose chemotherapy with hematopoietic stem cell rescue is allowed.

Exclusion Criteria:

- Failure to meet any of the above inclusion criteria.

- 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 (and for whom initial surgical extirpation is recommended) are
ineligible. Patients with unresectable late disease relapse are eligible.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number of objective responses (partial and complete responses) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 integrated with response of serum tumor markers.

Outcome Time Frame:

Six weeks after the first administration of the study drug.

Safety Issue:

No

Principal Investigator

Alessandro M Gianni, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fondazione IRCCS Istituto Nazionale dei Tumori

Authority:

Italy: The Italian Medicines Agency

Study ID:

FM-12-GCT01

NCT ID:

NCT01851200

Start Date:

May 2013

Completion Date:

June 2015

Related Keywords:

  • Germ Cell Cancer
  • Testicular neoplasms
  • Germ Cell cancers
  • Embryonal Carcinoma
  • Metastatic
  • Brentuximab Vedotin
  • Neoplasms, Germ Cell and Embryonal

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