Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects

November 25, 2014 updated by: Bayer

Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects Previously Untreated for Stage IV Disease

To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.

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.
198

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

  • Belgium
      • Antwerpen, Belgium, 2020
      • Bruxelles - Brussel, Belgium, 1070
      • Bruxelles - Brussel, Belgium, 1000
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
      • Liege, Belgium, 4000
  • Hungary
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1097
      • Budapest, Hungary, 1032
      • Debrecen, Hungary, 4032
      • Gyor, Hungary, 9024
      • Kecskemet, Hungary, 6000
      • Szeged, Hungary, 6720
      • Szekesfehervar, Hungary, 8000
  • Italy
      • Genova, Italy, 16132
      • Macerata, Italy, 62100
      • Palermo, Italy, 90146
      • Pordenone, Italy, 33170
      • Torino, Italy, 10153
      • Udine, Italy, 33100
      • Verona, Italy, 37134
    • Treviso
      • Castelfranco Veneto, Treviso, Italy, 31033
  • Poland
      • Bialystok, Poland, 15-027
      • Elblag, Poland, 82-300
      • Gdansk, Poland, 80-952
      • Gdynia, Poland, 81-519
      • Krakow, Poland, 31-501
      • Krakow, Poland, 31-115
      • Olsztyn, Poland, 10-228
      • Warszawa, Poland, 02-781
      • Warszawa, Poland, 04-141
      • Wroclaw, Poland, 53-413
  • Romania
      • Alba Iulia, Romania, 510039
      • Baia Mare, Romania, 430031
      • Bucharest, Romania, 022328
      • Bucharest, Romania, 022326
      • Cluj-Napoca, Romania, 400015
      • Craiova-Dolj, Romania, 200535
      • Iasi, Romania, 700106
      • Oradea, Romania, 410032
      • Suceava, Romania, 720237
      • Timisoara, Romania, 300239
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
      • Astrakhan, Russian Federation, 414041
      • Chelyabinsk, Russian Federation, 454087
      • Ekaterinburg, Russian Federation, 620036
      • Irkutsk, Russian Federation, 664035
      • Ivanovo, Russian Federation, 153013
      • Izhevsk, Russian Federation, 426009
      • Kazan, Russian Federation, 420029
      • Khabarovsk, Russian Federation, 680022
      • Krasnodar, Russian Federation, 350040
      • Kursk, Russian Federation, 305035
      • Magnitogorsk, Russian Federation, 455001
      • Moscow, Russian Federation, 115478
      • Moscow, Russian Federation, 121356
      • Moscow, Russian Federation, 129128
      • Nizhny Novgorod, Russian Federation, 603001
      • Novosibirsk, Russian Federation, 630047
      • Obninsk, Russian Federation, 249036
      • Pjatygorsk, Russian Federation, 357502
      • Rostov-on-Don, Russian Federation, 350086
      • Samara, Russian Federation, 443031
      • Sochi, Russian Federation, 354057
      • St. Petersburg, Russian Federation, 197022
      • St. Petersburg, Russian Federation, 197110
      • St. Petersburg, Russian Federation, 191104
      • St. Petersburg, Russian Federation, 194291
      • St. Petersburg, Russian Federation, 198255
      • Syktyvkar, Russian Federation, 167904
      • Tula, Russian Federation, 300053
      • Ulyanovsk, Russian Federation, 432063
      • Vladimir, Russian Federation, 600020
      • Volgograd, Russian Federation, 400138
      • Yaroslavl, Russian Federation, 150054
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28041
      • Málaga, Spain, 29010
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46010
      • Valencia, Spain, 46009
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Manresa, Barcelona, Spain, 08240
    • Cantabria
      • Santander, Cantabria, Spain, 39008
    • Illes Baleares
      • Palma de Mallorca, Illes Baleares, Spain, 07010
  • Ukraine
      • Cherkassy, Ukraine, 18009
      • Dnepropetrovsk, Ukraine, 49102
      • Dnipropetrovsk, Ukraine, 49055
      • Donetsk, Ukraine, 83092
      • Ivano-Frankovsk, Ukraine, 76000
      • Kharkov, Ukraine, 61070
      • Kiev, Ukraine, 03022
      • Krivoy Rog, Ukraine, 50048
      • Lugansk, Ukraine, 91047
      • Lviv, Ukraine, 79031
      • Mariupol, Ukraine, 87500
      • Sumy, Ukraine, 40005
      • Uzhgorod, Ukraine, 88014
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
      • Belfast, United Kingdom, BT7 1NN
      • Glasgow, United Kingdom, G61 1BD
      • Hull, United Kingdom, HU8 9HE
      • London, United Kingdom, WC1E 6BT
      • Manchester, United Kingdom, M20 4BX
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
      • Portsmouth, United Kingdom, PO6 3LY
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8ED
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
  • United States
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
      • Burlington, Massachusetts, United States, 01805
    • Texas
      • Dallas, Texas, United States, 75246

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:

  • Histological confirmation of adenocarcinoma of the colon or rectum
  • Tumor tissue sample available for KRAS and BRAF assessment
  • Measurable metastatic Stage IV disease including at least one measurable lesion that has not previously been radiated
  • No prior chemotherapy for metastatic CRC
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver, and renal function; adequate clotting parameters

Exclusion Criteria:

  • Prior treatment with sorafenib
  • Clinical or radiographic evidence of brain metastasis
  • Major surgery, surgical biopsy, or significant traumatic injury within 28 days of randomization; evidence or history of bleeding diathesis or coagulopathy
  • Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth factor use within 28 days before randomization
  • Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before randomization
  • Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within 28 days before randomization
  • Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of thrombosis due to placement of a semi-permanent central venous port for administration of chemotherapy is allowed. The use of coumadin and related compounds is excluded.)
  • Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg on repeated measurement) despite optimal medical management
  • Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident, including transient ischemic attacks) within 6 months before randomization

  • Active cardiac disease including:

    • Congestive heart failure
    • Unstable angina or myocardial infarction within the 6 months before randomization
    • Cardiac ventricular arrhythmias requiring antiarrhythmic treatment
  • Peripheral neuropathy > Grade 1 (CTCAE)
  • Known HIV infection or chronic hepatitis B or C infection
  • Any active infection >/= Grade 2 (CTCAE)
  • Any medical, psychological, or social condition that may interfere with the subject's participation in the study or evaluation of the study results
  • Use of any investigational drug within 28 days or 5 half-lives of that drug, whichever is longer, before randomization
  • Subjects with metastatic CRC who are currently candidates for surgery with curative intent

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: Quadruple

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: Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
Drug: Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
Placebo Comparator: Matching placebo + mFOLFOX6
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
Drug: Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease

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
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From randomization of the first subject until 23 months later, assessed every 8 weeks.
Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.
From randomization of the first subject until 23 months later, assessed every 8 weeks.

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
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization of the first subject until 33 months later.
Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
From randomization of the first subject until 33 months later.
Time to Progression (TTP)
Time Frame: From randomization of the first subject until 23 months later, assessed every 8 weeks.
Time to progression (TTP) was defined as the time from date of randomization to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.
From randomization of the first subject until 23 months later, assessed every 8 weeks.
Overall Response
Time Frame: From randomization of the first subject until 23 months later, assessed every 8 weeks.
Overall response of a subject was defined as the best tumor response (Complete Response (CR) or Partial Response (PR)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.
From randomization of the first subject until 23 months later, assessed every 8 weeks.
Duration of Response
Time Frame: From randomization of the first subject until 23 months later, assessed every 8 weeks
Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) was first documented or to the date of death, whichever occurred first according to Response Evaluation Criteria in Solid Tumors (RECIST). Subjects still having CR or PR and alive at the time of analysis were censored at their last date of tumor evaluation. CR was defined as disappearance of tumor lesions, PR as a decrease of at least 30% and PD as an increase of at least 20% in the sum of tumor lesions sizes.
From randomization of the first subject until 23 months later, assessed every 8 weeks

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.
Bayer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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.
March 1, 2009

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.
January 1, 2011

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.
February 1, 2012

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).
February 2, 2009

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 18, 2009

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 19, 2009

Study Record Updates

Last Update Posted (Estimate)

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.
December 11, 2014

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 25, 2014

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, 2014

More Information

Terms related to this study

Keywords

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.
  • 13162
  • 2008-005025-11 (EudraCT Number)

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.

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Conditions

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