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

Neoplasms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721266
• Other study ID #: BO21495
• Secondary ID: 2007-005939-28
• Status: Completed
• Phase: Phase 1
• First received: July 4, 2008
• Last updated: November 1, 2016
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agency for Medicines and Health Products
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RO5083945
Administered iv, either weekly, every 2 weeks or every 3 weeks, at escalating doses (with a starting dose of 50mg weekly (Part 1)). Recommended dose administered iv, either weekly, every 2 weeks or every 3 weeks (Part 2).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters, and maximum tolerated dose (Part 1)		Throughout study	No
Primary	Tumor growth control rate (CR, PR, SD) (Part 2)		Event driven	No
Secondary	AEs and laboratory parameters, pharmacodynamic parameters (Parts 1 and 2)		Throughout study	No
Secondary	Anti-tumor activity (ORR, DR, PFS) (Part 2)		Event driven	No