Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
E7080 · 1 trial · 1 indication
A treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study informed consent form (ICF), or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the mentioned criteria.
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study in ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A non-serious TEAE was any AE that was not considered a serious adverse event.
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. Related TEAE was defined as AE with causal relationship between the study drug and the TEAE.
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous.
| Arm | Type | Description |
|---|---|---|
| Cohort A : Lenvatinib | EXPERIMENTAL | The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study will continue to receive lenvatinib monotherapy. |
| Cohort B: Lenvatinib plus Comparator drug | EXPERIMENTAL | The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received lenvatinib combination therapy or who crossed over from a comparator arm to receive lenvatinib combination therapy in their parent study will continue to receive lenvatinib combination therapy. |
| Cohort C: Comparator drug | EXPERIMENTAL | The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received comparator treatment in their parent study will continue to receive comparator treatment, with exception of participants receiving placebo. For China only: The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received comparator treatment in their parent study will continue to receive sorafenib, with exception of participants receiving placebo. |
| Name | Type | Description |
|---|---|---|
| E7080 | DRUG | Oral Administration. |
| Comparator Drug | DRUG | Per parent study. |
| Comparator Drug: Sorafenib | DRUG | Per parent study. |
Inclusion Criteria: It is required for all participants currently participating in other lenvatinib studies to meet the following eligibility criteria. * Provide signed written informed consent for the roll-over study * Currently enrolled in an Eisai-sponsored lenvatinib clinical study and still r...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
E7080 is an investigational small molecule being studied for the treatment of solid tumors. It is currently in Phase 2 clinical development. The drug is being evaluated for its safety and tolerability in cancer patients, with a completed clinical trial that enrolled 40 participants.
E7080 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this investigational oncology drug for the treatment of solid tumors.
E7080 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in patients with solid tumors.
E7080 has one completed clinical trial registered under NCT03477175. This Phase 2 study assessed the long-term safety of lenvatinib monotherapy, a lenvatinib combination regimen, or a comparator treatment arm in cancer participants. The trial enrolled 40 participants with solid tumors across multiple countries.
E7080 is the drug name used in the clinical trial NCT03477175, which evaluates lenvatinib monotherapy and combination regimens. The trial is designed to assess the long-term safety of lenvatinib in cancer participants with solid tumors.