Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01103323
First received: April 8, 2010
Last updated: April 29, 2014
Last verified: April 2014

April 8, 2010
April 29, 2014
April 2010
July 2011   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 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). ] [ Designated as safety issue: No ]
Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.
Overall survival [ Time Frame: From randomisation of the first subject until 32 month later ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01103323 on ClinicalTrials.gov Archive Site
  • Progression-free Survival (Based on Investigator's Assessment) [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ] [ Designated as safety issue: No ]
    Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.
  • Objective Tumor Response [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ] [ Designated as safety issue: No ]
    The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis.
  • Disease Control [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ] [ Designated as safety issue: No ]
    Disease control was defined as the percentage of patients whose best response was not PD [sum of lesion sizes increased at least 20% from smallest sum on study or new lesions] (ie, CR [tumor disappears], PR [sum of lesion sizes decreased at least 30% from baseline] or SD (stable disease)). SD included if at least 6 weeks after randomization.
  • Tumor Response [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ] [ Designated as safety issue: No ]
    A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible.
  • Progression-free survival [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Objective tumor response rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Adverse event collection [ Time Frame: every 2-4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
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

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

All participants received Best Supportive Care. Acronyms used in Adverse events section: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE), International Normalized Ratio (INR), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Cranial nerves (CN), Disseminated Intravascular Coagulation (DIC), Cardiac troponin T (cTnT).

Abbreviation used in Results section: Data Monitoring Committee (DMC). Adverse event collection will be covered in Adverse events section.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Metastatic Colorectal Cancer
  • Drug: 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) plus Best Supportive Care
  • Drug: Placebo
    matching placebo tablets for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off) plus Best Supportive Care
  • Experimental: Regorafenib (Stivarga, BAY73-4506)
    Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle
    Intervention: Drug: Regorafenib (Stivarga, BAY73-4506)
  • Placebo Comparator: Placebo
    Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
760
January 2014
July 2011   (final data collection date for primary outcome measure)

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

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Turkey,   Germany,   Hungary,   Israel,   Italy,   Japan,   Netherlands,   Portugal,   Spain,   Switzerland
 
NCT01103323
14387, 2009-012787-14
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP