Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy (CONSIGN)

Expanded access is currently available for this treatment.
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01538680
First received: February 21, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access.

Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint of this study will be safety.


Condition Intervention
Colorectal Neoplasms
Drug: Regorafenib (BAY73-4506)

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

Resource links provided by NLM:


Further study details as provided by Bayer:

Intervention Details:
    Drug: Regorafenib (BAY73-4506)

    Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Subjects will continue on treatment until at least one of the following occurs (main criteria):

    Progressive Disease (PD). The subject may continue treatment at the investigator's discretion.

    Death Unacceptable toxicity Subject withdraws consent Treating physician determines discontinuation of treatment is in the subject's best interest Substantial non-compliance with the protocol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Male or female subjects 18 years of age
  • Life expectancy of at least 3 months
  • Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
  • Subjects with metastatic colorectal cancer (Stage IV)
  • Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type)
  • ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
  • Adequate bone marrow, liver and renal function
  • Women of childbearing potential and men must agree to use adequate contraception

Exclusion Criteria:

  • Prior treatment with regorafenib
  • Congestive heart failure >/= New York Heart Association (NYHA) class 2
  • Uncontrolled hypertension (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
  • Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
  • Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours)
  • Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity </= Grade 2
  • Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538680

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 206 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01538680     History of Changes
Other Study ID Numbers: 15967, 2011-005836-25
Study First Received: February 21, 2012
Last Updated: July 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Canadian Institutes of Health Research
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Direction Générale de la Santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Netherlands: Dutch Health Care Inspectorate
Poland: The Central Register of Clinical Trials
Spain: Ministry of Health and Consumption
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Greece: Ministry of Health and Welfare
Mexico: Federal Commission for Protection Against Health Risks
Norway: Norwegian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
Ireland: Irish Medicines Board
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 19, 2014