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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01327612 | Open Label Extension Study of Conatumumab and Ganitumab (AMG 479) | PHASE2 | COMPLETED | 12 | — | — | Mar 3, 2011 | Feb 5, 2020 | Feb 21, 2021 | 12 | United States, Poland +1 |
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.
A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other medically important serious event.
| Arm | Type | Description |
|---|---|---|
| Conatumumab Monotherapy | EXPERIMENTAL | Participants will continue to receive conatumumab every 2 weeks (Q2W) or every 3 weeks (Q3W) at the same dose and regimen as at the conclusion of the parent study. |
| Conatumumab + Ganitumab | EXPERIMENTAL | Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study. |
| Ganitumab Monotherapy | EXPERIMENTAL | Participants will continue to receive ganitumab Q3W or every 4 weeks (Q4W) at the same dose and regimen as at the conclusion of the parent study. |
| Conatumumab + mFOLFOX6 ± Bevacizumab | EXPERIMENTAL | Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab. |
| Name | Type | Description |
|---|---|---|
| Modified FOLFOX6 | DRUG | The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days. |
| Conatumumab | BIOLOGICAL | Administered by intravenous infusion Q2W or Q3W. |
| Ganitumab | BIOLOGICAL | Administered by intravenous infusion Q3W or Q4W. |
| Bevacizumab | BIOLOGICAL | Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle. |
Inclusion Criteria: * To be enrolled in this study, subjects must be currently enrolled in a prior Amgen-sponsored conatumumab or AMG 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or AMG 479 alone. Subjects must hav...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |