NCT01851200

Brief Summary

The purpose of the study is to assess the activity of Brentuximab vedotin in refractory germ cell tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 7, 2018

Status Verified

April 1, 2016

Enrollment Period

4.3 years

First QC Date

April 20, 2013

Last Update Submit

February 6, 2018

Conditions

Germ Cell Cancer

Keywords

Testicular neoplasmsGerm Cell cancersEmbryonal CarcinomaMetastaticBrentuximab Vedotin

Outcome Measures

Primary Outcomes (1)

  • 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.

    Six weeks after the first administration of the study drug.

Secondary Outcomes (3)

  • Progression-Free Survival

    3 months after the initiation of study treatment

  • Overall Survival

    Six months after the initiation of study treatment

  • Incidence of adverse events related to the study drug

    Six weeks after the initiation of the study drug and every 6 weeks thereafter up to 16 weeks.

Other Outcomes (1)

  • Metabolic response to Brentuximab Vedotin measured by means of a Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) scan.

    Six weeks after the first administration of the study drug.

Study Arms (1)

Brentuximab Vedotin

EXPERIMENTAL

Intravenous Brentuximab Vedotin at the dose of 1.8 mg/Kg every 3 weeks until disease progression or onset of unacceptable toxicity

Drug: Brentuximab Vedotin

Interventions

Brentuximab VedotinDRUG

Intravenous Brentuximab Vedotin at the dose of 1.8 mg/Kg every 3 weeks until disease progression or onset of unacceptable toxicity

Also known as: SGN-35, Adcetris
Brentuximab Vedotin

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Mi, 20133, Italy

Location

Related Links

MeSH Terms

Conditions

Neoplasms, Germ Cell and EmbryonalTesticular NeoplasmsCarcinoma, EmbryonalNeoplasm Metastasis

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Alessandro M Gianni, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    STUDY CHAIR

  • Roberto Salvioni, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    STUDY CHAIR

  • Andrea Necchi, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2013

First Posted

May 10, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

February 7, 2018

Record last verified: 2016-04

Locations

IT(1)