Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01862003 | Phase I/II Trial of Antagonism of HER in GI Cancer | PHASE2 | COMPLETED | 24 | — | — | May 1, 2014 | Aug 2, 2019 | Aug 19, 2019 | 4 | United Kingdom |
Best overall response will be assessed according to RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | AZD8931 160 mg bd, on days 1-4, + FOLFIRI in a 2 weekly schedule |
| Name | Type | Description |
|---|---|---|
| AZD8931 | DRUG | 160 mg AZD8931 tablets, twice daily on days 1 - 4 of each 2-weekly cycle |
| Irinotecan | DRUG | 180 mg/m2 (IV infusion) of Irinotecan on day 1 of each 2-weekly cycle - can be given simultaneously with Folinic acid. |
| Folinic Acid | DRUG | 350 mg (IV infusion) of Folinic acid on day 1 of each 2-weekly cycle - can be given simultaneously with Irinotecan. |
| Fluorouracil | DRUG | 400 mg/m2 (IV bolus) of Fluorouracil on day 1 of each 2-weekly cycle, to be given after completion of Irinotecan and Folinic acid. |
Inclusion Criteria: 1. Histopathological/cytological diagnosis of non-resectable, recurrent or metastatic colorectal cancer 2. Tumour with wild-type RAS 3. Measurable disease evaluated by RECIST criteria v1.1 4. WHO performance status 0 or 1 5. Age ≥ 16 6. Estimated life expectancy \> 3 months 7. A...