NCT02013765

Brief Summary

This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
terminated

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

Study Start

First participant enrolled

January 1, 2001

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

September 25, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

9 years

First QC Date

December 3, 2013

Results QC Date

July 24, 2014

Last Update Submit

September 22, 2014

Conditions

Urinary Tract Cancer

Outcome Measures

Primary Outcomes (3)

  • Progression-Free Survival (PFS) - Percentage of Participants With an Event

    PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.

    Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment

  • Progression-Free Survival - Time to Event

    The median time, in months, from the first study drug treatment to a PFS event.

    Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment

  • Percentage of Participants Progression Free at 12 and 24 Months

    Months 12 and 24

Secondary Outcomes (4)

  • Overall Survival (OS) - Percentage of Participants With an Event

    Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter

  • Overall Survival - Time to Event

    Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter

  • Percentage of Participants Surviving at 12 and 24 Months

    Months 12 and 24

  • Percentage of Participants by Best Overall Response to Treatment

    Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment

Study Arms (1)

Trastuzumab Monotherapy

EXPERIMENTAL

Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by weekly doses of 2 mg/kg IV beginning on Day 8 and continuing for up to 37 weeks.

Drug: trastuzumab

Interventions

trastuzumabDRUG

Initial dose of 4 mg/kg i.v on Day 1, followed by weekly doses of 2 mg/kg i.v. beginning on Day 8 and continuing for up to 37 weeks.

Also known as: Herceptin
Trastuzumab Monotherapy

Eligibility Criteria

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

You may qualify if:

  • adult patients \>=18 years of age;
  • metastatic urothelial cancer;
  • disease progression during or after 1 prior platinum-based chemotherapy;
  • measurable disease;
  • HER2 overexpression (IHC \[2+\] or \[3+\]).

You may not qualify if:

  • concomitant chemotherapy or immunotherapy;
  • active or uncontrolled infection;
  • solely CNS metastases;
  • clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
  • co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Aschersleben, 06449, Germany

Location

Unknown Facility

Dessau, 06846, Germany

Location

Unknown Facility

Fulda, 36043, Germany

Location

Unknown Facility

Leipzig, 04103, Germany

Location

Unknown Facility

Leipzig, 04277, Germany

Location

Unknown Facility

Marburg, 35043, Germany

Location

Unknown Facility

Weiden, 92637, Germany

Location

MeSH Terms

Conditions

Urologic Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Communications
Organization
Hoffman-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 17, 2013

Study Start

January 1, 2001

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

September 25, 2014

Results First Posted

September 25, 2014

Record last verified: 2014-09

Locations

DE(7)