Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004717

Trial Description

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Title

An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

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Trial Acronym

CONSIGN

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004717
  •   2014/03/17
  •   2012/02/21
  •   no
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Secondary IDs

  •   2011-005836-25 
  •   NCT01538680  (ClinicalTrials.gov)
  •   15967  (Bayer)
  •   2011-005836-25 
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Health Condition or Problem studied

  •   Colorectal Neoplasms
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Drug: Regorafenib (BAY73-4506)
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Characteristics

  •   Interventional
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  •   N/A
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Primary Outcome

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Secondary Outcome

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Ireland
  •   Israel
  •   Italy
  •   Mexico
  •   Netherlands
  •   Norway
  •   Poland
  •   Portugal
  •   Russian Federation
  •   Spain
  •   Sweden
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer Clinical Trials Contact 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2014/03/13
* This entry means the parameter is not applicable or has not been set.