A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer

November 16, 2022 updated by: Hoffmann-La Roche

A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer

This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2298
      • Port Macquarie, New South Wales, Australia, 2444
    • South Australia
      • Adelaide, South Australia, Australia, 5041
    • Victoria
      • Box Hill, Victoria, Australia, 3128
      • EAST Bentleigh, Victoria, Australia, VIC 3165
      • Frankston, Victoria, Australia, 3199
  • Belgium
      • Bruxelles, Belgium, 1200
      • Bruxelles, Belgium, 1000
      • Edegem, Belgium, 2650
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
  • France
      • Bordeaux, France, 33075
      • Brest, France, 29200
      • Lille, France, 59037
      • Paris, France, 75679
      • Saint Herblain, France, 44805
      • Toulouse, France, 31059
  • Germany
      • Essen, Germany, 45122
      • Hamburg, Germany, 20246
      • Hannover, Germany, 30625
      • Heidelberg, Germany, 69120
      • Herne, Germany, 44625
      • Regensburg, Germany, 93049
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
    • Lombardia
      • Milano, Lombardia, Italy, 20132
      • Milano, Lombardia, Italy, 20162
      • Milano, Lombardia, Italy, 20141
      • Pavia, Lombardia, Italy, 27100
  • Poland
      • Olsztyn, Poland, 10-228
      • Szczecin, Poland, 70-111
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08907
      • Madrid, Spain, 28007
      • Madrid, Spain, 28050
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46010
    • Barcelona
      • Sabadell, Barcelona, Barcelona, Spain, 08208
    • Cantabria
      • Santander, Cantabria, Spain, 39008
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
      • Belfast, United Kingdom, BT9 7AB
      • Bournemouth, United Kingdom, BH7 7DW
      • Cardiff, United Kingdom, CF14 2TL
      • Dorchester, United Kingdom, DT1 2JY
      • Glasgow, United Kingdom, G12 0YN
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, SW3 6JJ
      • London, United Kingdom, WC1E 6DD
      • Northwood, United Kingdom, HA6 2RN
      • Romford, United Kingdom, RM7 0AG
      • Weston Super Mare, United Kingdom, BS23 4TQ
  • United States
    • California
      • Encinitas, California, United States, 92024
      • Highland, California, United States, 92346
      • La Jolla, California, United States, 92037
      • La Verne, California, United States, 91750
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90033
      • San Diego, California, United States, 92123
    • Illinois
      • Harvey, Illinois, United States, 60426
      • Skokie, Illinois, United States, 60076
      • Skokie, Illinois, United States, 60077
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Durham, North Carolina, United States, 27710
      • Winston-Salem, North Carolina, United States, 27103
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
    • South Carolina
      • Greenville, South Carolina, United States, 29615
    • Tennessee
      • Memphis, Tennessee, United States, 38119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Carcinoma of the colon and/or rectum
  • Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease
  • ECOG performance status 0-1
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (EGFR)
  • Prior treatment with irinotecan
  • Radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief)
  • CNS metastasis
  • History of or active autoimmune disorders/conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: KRAS WT A
Drug: FOLFIRI
standard iv chemotherapy
Drug: RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
Active Comparator: KRAS WT B
Drug: FOLFIRI
standard iv chemotherapy
Drug: cetuximab
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
Experimental: KRAS mutant A
Drug: FOLFIRI
standard iv chemotherapy
Drug: RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
Active Comparator: KRAS mutant B
Drug: FOLFIRI
standard iv chemotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
Time Frame: approximately 18 months
approximately 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
Time Frame: approximately 18 months
approximately 18 months
Duration of response: time from complete or partial response to disease progression or death
Time Frame: approximately 18 months
approximately 18 months
Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria
Time Frame: approximately 18 months
approximately 18 months
Overall survival
Time Frame: approximately 18 months
approximately 18 months
Safety: Incidence of adverse events
Time Frame: approximately 18 months
approximately 18 months
Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa
Time Frame: approximately 18 months
approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP25438

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings