NCT01482377 - A Study of RO5479599 Alone or in Combination With Cetuximab or Erlotinib in Participants With Metastatic and/or Locally Advanced Malignant Human Epidermal Growth Factor Receptor (HER3) Expressing Solid Tumors of Epithelial Cell Origin | Biotech Hunter

Enrollment

145

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions

Neoplasms

Interventions

DRUG

RO5479599

RO5479599 will be administered Q2W or Q3W (other regimen could be explored based on observations during dose escalation part).

DRUG

Cetuximab

Cetuximab will be administered via intravenous (IV) infusion at a starting dose of 400 mg/m\^2 for the first infusion, followed by doses of 250 mg/m\^2 for subsequent infusions.

DRUG

Erlotinib

Erlotinib, at a dose of 150 mg will be administered.

DRUG

zirconium-89-labeled RO5479599

Single dose of radiolabeled drug will be administered.

Trial Locations (12)

2100

Rigshospitalet, Onkologisk Klinik, København Ø

10408

National Cancer Center, Gyeonggi-do

28050

Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid

41013

Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Seville

46010

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia

1066 CX

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam

9713 GZ

Academ Ziekenhuis Groningen; Medical Oncology, Groningen

3075EA

Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed, Rotterdam

3584 CW

Utrecht University Medical Centre; Dept of Medical Oncology and UPC, Utrecht

05505

Asan Medical Center, Seoul

08003

Hospital del Mar; Servicio de Oncologia, Barcelona

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY