Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
standard second line treatment, at discretion of the investigator · 1 trial · 1 indication
Progression Free Survival rate at 6 months(PFS rate at 6-months) is defined as the rate of assessable patients alive and not progressed after 6 months from study initiation (i.e randomization) to the first documentation of objective disease progression by RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Regorafenib for ARM A - experimental arm | EXPERIMENTAL | Regorafenib will be administered following a dose-escalation strategy: starting dose 80 mg/day orally with weekly escalation, per 40 mg increment up to 160 mg/day regorafenib); if no significant drug-related adverse events occurred for 21 days of a 28-day cycle. The following cycle will be administered at highest tolerated dose from cycle 1 (up to 160 mg), as per current guidelines and clinical practice. Treatment will continue until disease progression, unacceptable toxic effects, motivated decision to stop the treatment by the treating physician, or refusal or withdrawal of consent by the patient. |
| Standard treatment for ARM B - calibration arm | ACTIVE_COMPARATOR | Patients will continue to receive study treatment until treatment failure as previous defined, unacceptable toxicity, physician's decision, patient's refusal, or any other discontinuation criteria. |
| Name | Type | Description |
|---|---|---|
| standard second line treatment, at discretion of the investigator | DRUG | Combination treatment may include: 5FU/LFA, capecitabine, oxaliplatin, irinotecan, bevacizumab, aflibercept |
| Regorafenib (BAY73-4506) | DRUG | Regorafenib will be administered following a dose-escalation strategy: starting dose 80 mg/day orally with weekly escalation, per 40 mg increment up to 160 mg/day regorafenib); if no significant drug-related adverse events occurred for 21 days of a 28-day cycle. The following cycle will be administered at highest tolerated dose from cycle 1 (up to 160 mg), as per current guidelines and clinical practice. Treatment will continue until disease progression, unacceptable toxic effects, motivated decision to stop the treatment by the treating physician, or refusal or withdrawal of consent by the patient. Every cycle will be administered every 28 days (four weeks) +/- 3 days. |
Inclusion Criteria: 1. Written informed consent to study procedures and to correlative studies. 2. Either sex aged ≥ 18. 3. Histologically proven of colorectal adenocarcinoma. 4. Diagnosis of metastatic disease. 5. RAS mutant at initial diagnosis assessed at local centers according with a validated...
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