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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01991873 | Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer | PHASE2 | COMPLETED | 387 | — | — | Apr 1, 2014 | Feb 18, 2023 | Jun 15, 2023 | 2 | Germany |
Progression-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first.
| Arm | Type | Description |
|---|---|---|
| Maintenance Chemotherapy + Panitumumab | EXPERIMENTAL | Maintenance therapy: Panitumumab 6 mg/kg prior to administration of chemotherapy Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15 Re-induction upon progression: Panitumumab 6 mg/kg prior to administration of mFOLFOX6 chemotherapy. mFOLFOX6: Oxaliplatin 85 mg/m2 over 2 hours on day 1 Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15 |
| Maintenance Chemotherapy w/o Panitumumab | EXPERIMENTAL | Maintenance therapy: Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15 Re-induction upon progression: Panitumumab 6 mg/kg prior to administration of mFOLFOX6 chemotherapy. mFOLFOX6 chemotherapy: Oxaliplatin 85 mg/m2 over 2 hours on day 1 Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15 |
| Name | Type | Description |
|---|---|---|
| Maintenance Chemotherapy | DRUG | - |
| Panitumumab (Within maintenance phase) | DRUG | - |
| mFOLFOX6 (Within re-induction phase) | DRUG | - |
| Panitumumab (Within re-induction phase) | DRUG | - |
Inclusion Criteria: * Signed written informed consent * Male or female ≥ 18 years of age * Histologically proven metastatic colorectal cancer * Molecular testing showing RAS wild-type in colorectal carcinoma cells * Life expectancy \> 12 weeks * At least one measurable lesion according to RECIST 1....