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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01103323




Registration number
NCT01103323
Ethics application status
Date submitted
8/04/2010
Date registered
14/04/2010
Date last updated
24/06/2015

Titles & IDs
Public title
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
Secondary ID [1] 0 0
2009-012787-14
Secondary ID [2] 0 0
14387
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 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 - Placebo
Other interventions - Best Supportive Care (BSC)

Experimental: Regorafenib (Stivarga, BAY73-4506)+BSC - Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care(BSC).

Placebo Comparator: Placebo+BSC - Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care (BSC).


Treatment: Drugs: Regorafenib (Stivarga, BAY73-4506)
160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

Treatment: Drugs: Placebo
matching placebo tablets for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

Other interventions: Best Supportive Care (BSC)
BSC includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).
Secondary outcome [1] 0 0
Progression-free Survival (Based on Investigator's Assessment)
Timepoint [1] 0 0
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
Secondary outcome [2] 0 0
Objective Tumor Response
Timepoint [2] 0 0
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
Secondary outcome [3] 0 0
Disease Control
Timepoint [3] 0 0
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
Secondary outcome [4] 0 0
Tumor Response
Timepoint [4] 0 0
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.

Eligibility
Key inclusion criteria
- Histological or cytological documentation of adenocarcinoma of the colon or rectum

- Progression during or within 3 months following the last administration of approved
standard therapies. Patients treated with oxaliplatin in an adjuvant setting should
have progressed during or within 6 months of completion of adjuvant therapy

- Patients with measurable or non measurable disease

- Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 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
- Unstable/uncontrolled cardiac disease

- History of arterial or venous thrombotic or embolic events

- Symptomatic metastatic brain or meningeal tumors

- Patients with evidence or history of bleeding diathesis

- Interstitial lung disease - Persistent proteinuria >/= grade 3

- Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding
alopecia and oxaliplatin induced neurotoxicity </= Grade 2

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
760
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- St Leonards
Recruitment hospital [3] 0 0
- Woolloogabba
Recruitment hospital [4] 0 0
- Woodville South
Recruitment hospital [5] 0 0
- Footscray
Recruitment hospital [6] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4102 - Woolloogabba
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled multi-center phase III study to
evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer
(CRC) who have progressed on/after all approved drugs for CRC
Trial website
https://clinicaltrials.gov/ct2/show/NCT01103323
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01103323