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

Bayer

Status and phase: Completed; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Placebo; Other: Best Supportive Care (BSC); Drug: Regorafenib (Stivarga, BAY73-4506)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103323

14387

2009-012787-14 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 760 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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760 participants in 2 patient groups, including a placebo group

Regorafenib (Stivarga, BAY73-4506)+BSC

Experimental group

Description:

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).

Treatment:

Drug: Regorafenib (Stivarga, BAY73-4506)

Other: Best Supportive Care (BSC)

Placebo+BSC

Placebo Comparator group

Description:

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:

Drug: Placebo

Other: Best Supportive Care (BSC)