Status:
COMPLETED
A Dose-Escalation Study of RO5083945 in Patients With Metastatic and/or Locally Advanced Malignant Epidermal Growth Factor Receptor (EGFR)+ Solid Tumors.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 firs...
Eligibility Criteria
Inclusion
- 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
- history of grade 3-4 toxicity resulting from previous anti-EGFR treatment;
- known or suspected CNS metastases;
- wild type KRAS colorectal cancer (Part 2).
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00721266
Start Date
June 1 2008
End Date
June 1 2011
Last Update
November 2 2016
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Toulouse, France, 31059
2
Villejuif, France, 94805
3
Barcelona, Barcelona, Spain, 08035
4
Seville, Sevilla, Spain, 41013