Colorectal Neoplasms
Conditions
Brief summary
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.
Interventions
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
Sponsors
Bayer
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed