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PURO Panitumumab in Combination With Gemcitabine/Cisplatin in Advanced Urothelial Cancer

NCT01374789 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-06-03

No results posted yet for this study

Summary

The primary objective of the study is to assess the efficacy of the combination consisting of gemcitabine/cisplatin and panitumumab in patients with urothelial carcinoma and wild-type HRAS (non-mutated status). The progression-free survival rate at 12 months will be compared to expectations derived from historical data, which are verified by a randomised control group without the antibody.

Conditions

  • Urinary Bladder Cancer

Interventions

DRUG

GemCis + Panitumumab

Gemcitabine: 1250 mg/m², day 1 and 8, i.v., q3 Cisplatin: 70 mg/m², day 2, i.v., q3 Panitumumab 9 mg/kg/body weight, i.v., day 1,q3

DRUG

GemCis

Gemcitabine: 1250 mg/m², day 1 and 8, i.v., q3 Cisplatin: 70 mg/m², day 2, i.v., q3

Sponsors & Collaborators

  • Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

    collaborator OTHER

  • WiSP Wissenschaftlicher Service Pharma GmbH

    lead OTHER

Principal Investigators

  • Kurt Miller, Prof. Dr. · Universitätsmedizin Charité Berlin, Klinik für Urologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01374789 on ClinicalTrials.gov