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



Status:No longer available
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018

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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

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.


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
We found this trial at
62
sites
976
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Winston-Salem, NC
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808
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Ann Arbor, MI
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801
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Atlanta, GA
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Aventura, FL
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Boston, MA
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Brewer, ME
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Bronx, NY
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1438
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Burlington, MA
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437
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Cedar Rapids, IA
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Charleston, South Carolina 29412
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Charleston, SC
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Charlotte, North Carolina 28207
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Charlotte, NC
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726
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Cincinnati, OH
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Cleveland, OH
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811
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Columbus, GA
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15 Concord Road
Concord, New South Wales 2137
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Concord,
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349
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Dallas, TX
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409
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Denver, CO
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Detroit, MI
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841
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Detroit, MI
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Duarte, CA
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635
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Fargo, ND
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Jackson, MS
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Jacksonville, FL
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307
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Jefferson City, MO
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La Jolla, CA
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La Jolla, CA
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Lake Success, NY
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Las Vegas, NV
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1393
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Lebanon, NH
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1171
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Long Beach, CA
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1168
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Los Angeles, CA
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657
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Louisville, KY
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467
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Memphis, TN
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1323
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Miami Beach, FL
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618
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Nashville, TN
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New Haven, CT
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New Orleans, LA
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New York, NY
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1290
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New York, NY
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New York, NY
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Ocala, FL
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262
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Omaha, NE
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1154
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Orange, CA
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Orlando, FL
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604
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Park Ridge, IL
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Philadelphia, PA
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Philadelphia, PA
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Portland, OR
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Portsmouth, VA
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1424
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Providence, RI
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Richmond, VA
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515
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Rochester, MN
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1266
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Santa Maria, CA
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1026
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Savannah, GA
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Seattle, WA
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429
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Shreveport, LA
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336
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Sioux City, IA
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Stony Brook, NY
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Sumter, SC
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460
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Temple, TX
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805
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Toledo, OH
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1127
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Washington,
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