NCT00721266

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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2008

Typical duration for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2008

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

July 4, 2008

Last Update Submit

November 1, 2016

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic parameters, and maximum tolerated dose (Part 1)

    Throughout study

  • Tumor growth control rate (CR, PR, SD) (Part 2)

    Event driven

Secondary Outcomes (2)

  • AEs and laboratory parameters, pharmacodynamic parameters (Parts 1 and 2)

    Throughout study

  • Anti-tumor activity (ORR, DR, PFS) (Part 2)

    Event driven

Study Arms (1)

1

EXPERIMENTAL
Drug: RO5083945

Interventions

RO5083945DRUG

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).

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • history of grade 3-4 toxicity resulting from previous anti-EGFR treatment;
  • known or suspected CNS metastases;
  • wild type KRAS colorectal cancer (Part 2).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Barcelona, Barcelona, 08035, Spain

Location

Unknown Facility

Seville, Sevilla, 41013, Spain

Location

Unknown Facility

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

  • Paz-Ares LG, Gomez-Roca C, Delord JP, Cervantes A, Markman B, Corral J, Soria JC, Berge Y, Roda D, Russell-Yarde F, Hollingsworth S, Baselga J, Umana P, Manenti L, Tabernero J. Phase I pharmacokinetic and pharmacodynamic dose-escalation study of RG7160 (GA201), the first glycoengineered monoclonal antibody against the epidermal growth factor receptor, in patients with advanced solid tumors. J Clin Oncol. 2011 Oct 1;29(28):3783-90. doi: 10.1200/JCO.2011.34.8888. Epub 2011 Sep 6.

    PMID: 21900113DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

imgatuzumab

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2008

First Posted

July 24, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(3)FR(2)