A Dose-Escalation Study of RO5083945 in Patients With Metastatic and/or Locally Advanced Malignant Epidermal Growth Factor Receptor (EGFR)+ Solid Tumors.

Roche

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: RO5083945

Study type

Interventional

Funder types

Industry

Identifiers

NCT00721266

BO21495

2007-005939-28

Details and patient eligibility

About

This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The starting dose of 50mg weekly will be escalated in subsequent groups of patients after a successful assessment of the safety, tolerability and pharmacokinetics of the previous dose. In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, >=18 years of age;
centrally confirmed EGFR expression in tumor tissue;
radiologically measurable or clinically evaluable disease;
last dose of systemic anti-neoplastic therapy or radiotherapy >=28 days prior to start of study;
histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ solid tumors (Part 1);
histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ and mutant KRAS colorectal cancer (Part 2);
not more than 2 previous cytotoxic regimens for metastatic disease (Part 2).

Exclusion criteria