First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01289821
First received: February 3, 2011
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: April 9, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Neoplasms
Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Oxaliplatin
Drug: Folinic acid
Drug: 5-FU (mFOLFOX6)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Male or female participants with histological or cytological documentation of adenocarcinoma of the colon or rectum that was unresectable or unlikely of becomining resectable, who were at least 18 years of age and were suitable to receive mFOLFOX6 regimen as first line treatment could participate in this study at 16 centers in 7 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 66 enrolled participants, 54 received study medication, 4 withdrew consent during screening, and 8 were screen failures due to no measurable lesion, not suitable to receive mFOLFOX as 1st line regimen (2), uncontrolled hypertension, symptoms/signs/history of brain metastases, glomerular filtration rate too low (2), and protein in spot urine

Reporting Groups
  Description
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.

Participant Flow for 3 periods

Period 1:   Treatment Period
    Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)  
STARTED     54  
Participants Received Regorafenib     53  
COMPLETED     26  
NOT COMPLETED     28  
Withdrawal by Subject                 1  
Physician Decision                 3  
Adverse Event                 3  
Radiological Progression                 19  
Clinical Progression                 2  

Period 2:   Safety Follow-up Period
    Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)  
STARTED     26  
COMPLETED     22  
NOT COMPLETED     4  
Death                 1  
Withdrawal by Subject                 1  
Protocol Violation                 2  

Period 3:   Survival Follow-up Period
    Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)  
STARTED     22  
COMPLETED     16  
NOT COMPLETED     6  
Death                 5  
Protocol Violation                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.

Baseline Measures
    Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)  
Number of Participants  
[units: participants]
  54  
Age, Customized  
[units: Participants]
 
< 65 years     33  
65 - 75 years     18  
> 75 years     3  
Gender  
[units: Paricipants]
 
Female     26  
Male     28  
Caucasian  
[units: Participants]
  54  
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at study entry [1]
[units: Participants]
 
0     35  
1     19  
Stage at initial diagnosis [2]
[units: Participants]
 
I     1  
IIA     5  
IIIB     3  
IIIC     4  
IV     41  
[1] The ECOG PS required for the study was 0 (fully active) or 1 (restricted in physically strenous activity but ambulatory and able to carry out work of a light or sedentary nature)
[2] The TNM Classification of Malignant Tumors (TNM) is a cancer staging system that describes the extent of a person's cancer. T describes the size of the original (primary) tumor and whether it has invaded nearby tissue, N describes nearby (regional) lymph nodes that are involved, M describes distant metastasis. For colon carcinoma, this is translated into stages I-IV. Stages II-IV can be further subdivided in subgroups (eg, A,B, or C).



  Outcome Measures
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1.  Primary:   Objective Response (OR)   [ Time Frame: From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks. ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From start of treatment of first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks. ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks. ]

4.  Secondary:   Disease Control (DC)   [ Time Frame: From start of treatmentof the first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks. ]

5.  Secondary:   Duration of Response (DOR)   [ Time Frame: From start of treatment of first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks. ]

6.  Secondary:   Duration of Stable Disease (DOSD)   [ Time Frame: From start of treatment of first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided by Bayer

Publications automatically indexed to this study:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01289821     History of Changes
Other Study ID Numbers: 11728, 2010-020121-41
Study First Received: February 3, 2011
Results First Received: April 9, 2013
Last Updated: July 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Ministry of Health and Consumption
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration