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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

NCT01482377 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2017-01-27

No results posted yet for this study

Summary

This dose-escalating study consists of 3 parts (A, B and C) and will evaluate the safety, pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or erlotinib, in participants with metastatic and/or locally advanced malignant HER3-positive solid tumors. Cohorts of participants will receive escalating doses of intravenous RO5479599 as monotherapy (Part A) or in combination with cetuximab (in Part B) or with erlotinib (in Part C) followed by an extension phase for each part.

In an imaging substudy, participants will receive one or two doses of zirconium-89-labeled RO5479599 (89ZrRO5479599) in addition to unlabeled RO5479599 to evaluate the in vivo biodistribution and organ pharmacokinetics of RO5479599.

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Denmark
  • Netherlands
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01482377 on ClinicalTrials.gov