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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms

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Trial Information

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


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
- 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

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

15967

NCT ID:

NCT01538680

Start Date:

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Kansas City, Kansas  66160
Scarborough, Maine  04074
Omaha, Nebraska  68114
Metairie, Louisiana  70006
Denver, Colorado  
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Charleston, South Carolina  
Lebanon, New Hampshire  
Providence, Rhode Island  02908
Washington, District of Columbia  
Las Vegas, Nevada  89109
Bismarck, North Dakota  58501