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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

18 Years
Open (Enrolling)
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
- 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:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms



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