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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01289821




Registration number
NCT01289821
Ethics application status
Date submitted
3/02/2011
Date registered
4/02/2011
Date last updated
15/03/2017

Titles & IDs
Public title
First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
Scientific title
An Uncontrolled, Open-label, Phase II Study in Subjects With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First Line Chemotherapy With mFOLFOX6 (Oxaliplatin/ Folinic Acid/5-fluorouracil [5-FU]) in Combination With Regorafenib
Secondary ID [1] 0 0
2010-020121-41
Secondary ID [2] 0 0
11728
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Regorafenib (Stivarga, BAY73-4506)
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Folinic acid
Treatment: Drugs - 5-FU (mFOLFOX6)

Experimental: Regorafenib + oxaliplatin/folinic acid/5-FU (mFOLFOX6) - On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 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.


Treatment: Drugs: Regorafenib (Stivarga, BAY73-4506)
Subjects will receive regorafenib 160 mg od on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets. In case of administration as a single agent during the study, regorafenib will be administered 160 mg od for 3 weeks on/1 week off. Each cycle consists of 28 days.

Treatment: Drugs: Oxaliplatin
On day 1 and day 15 of each cycle, participants will receive 85 mg/m\^2 oxaliplatin as a 2 hour i.v. infusion.

Treatment: Drugs: Folinic acid
On day 1 and day 15 of each cycle, participants will receive folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2 hour i.v. infusion.

Treatment: Drugs: 5-FU (mFOLFOX6)
Participants will receive a 400 mg/m\^2 5 FU i.v. bolus injection immediately followed by a 2400 mg/m\^2 5 FU 46 hour i.v. infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response (OR)
Timepoint [1] 0 0
From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks
Secondary outcome [2] 0 0
Progression-free Survival (PFS)
Timepoint [2] 0 0
From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks
Secondary outcome [3] 0 0
Disease Control (DC)
Timepoint [3] 0 0
From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks
Secondary outcome [5] 0 0
Duration of Stable Disease (DOSD)
Timepoint [5] 0 0
From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks

Eligibility
Key inclusion criteria
* Male or female subjects aged = 18 years
* Histological or cytological documentation of adenocarcinoma of the colon or rectum
* Suitable to receive mFOLFOX6 regimen as first line metastatic treatment
* At least 1 measurable lesion as per RECIST version 1.1
* Unresectable or unlikely becoming resectable metastatic disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 3 months
* Adequate bone marrow, liver, and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic anticancer therapy for metastatic colorectal cancer (CRC). Adjuvant chemotherapy for CRC (Stage I, II, III) is permitted, if the adjuvant therapy ended > 6 months before screening and recurrent disease was documented.
* Prior treatment with antivascular endothelial growth factor (anti-VEGF) agents and any signal transduction inhibitors (STIs)
* Uncontrolled hypertension
* Subjects with symptoms, signs, or history of brain metastases
* Any hemorrhage or bleeding event = Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks of start of study treatment
* Sensory neuropathy (> CTCAE Grade 1), unresolved toxicity > CTCAE Grade 1 attributed to any prior therapy/procedure excluding alopecia

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Woodville South
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles - Brussel
Country [3] 0 0
Belgium
State/province [3] 0 0
Edegem
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Germany
State/province [5] 0 0
Baden-Württemberg
Country [6] 0 0
Germany
State/province [6] 0 0
Niedersachsen
Country [7] 0 0
Germany
State/province [7] 0 0
Nordrhein-Westfalen
Country [8] 0 0
Germany
State/province [8] 0 0
Sachsen
Country [9] 0 0
Italy
State/province [9] 0 0
Campania
Country [10] 0 0
Italy
State/province [10] 0 0
Liguria
Country [11] 0 0
Italy
State/province [11] 0 0
Marche
Country [12] 0 0
Spain
State/province [12] 0 0
Cantabria
Country [13] 0 0
Spain
State/province [13] 0 0
Barcelona
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Glasgow
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Schultheis B, Folprecht G, Kuhlmann J, Ehrenberg R... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01289821