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An Open Label, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Tumor Growth Control Rate of RO5083945, a Glycoengineered Antibody Against EGFR, in Patients With Metastatic and/or Locally Advanced Malignant EGFR+ Solid Tumors.


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

An Open Label, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Tumor Growth Control Rate of RO5083945, a Glycoengineered Antibody Against EGFR, in Patients With Metastatic and/or Locally Advanced Malignant EGFR+ Solid Tumors.


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:

- history of grade 3-4 toxicity resulting from previous anti-EGFR treatment;

- known or suspected CNS metastases;

- wild type KRAS colorectal cancer (Part 2).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic parameters, and maximum tolerated dose (Part 1)

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Agency for Medicines and Health Products

Study ID:

BO21495

NCT ID:

NCT00721266

Start Date:

June 2008

Completion Date:

June 2011

Related Keywords:

  • Neoplasms
  • Neoplasms

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