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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03152370 | Preoperative Radiotherapy and E7046 in Rectum Cancer | PHASE1 | COMPLETED | 29 | — | — | May 17, 2017 | Sep 30, 2021 | Oct 4, 2021 | 5 | United States, Poland +1 |
The MTD is defined as one dose level below the dose level where ≥2 of 6 participants experience a dose-limiting toxicity (DLT; study drug-related toxicity) (ie, ≥33% of participants with a DLT at that dose level).
DLTs are defined as study drug-related toxicities meeting specified grades per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.03.
An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse event as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product.
| Arm | Type | Description |
|---|---|---|
| E7046 in combination with Long Course Chemoradiotherapy (LCRT) | EXPERIMENTAL | Participants will receive once daily (QD) doses of E7046 (recommended Phase 2 dose \[RP2D\] determined in the Dose-Escalation part of the study) for 10 weeks, starting on Day 1, 14 days prior to initiation of the radiotherapy. LCRT will be initiated on Day 15 and will consist of a total of 45 Grays (GY) radiation administered in 1.8 GY daily doses delivered for 5 days (Monday to Friday) every week for 5 weeks. Capecitabine (825 milligrams per meters squared \[mg/m\^2\]) will be administered twice daily on the days of radiotherapy. Surgery will be performed 14 to 16 weeks from the first day of E7046 treatment. |
| E7046 in combination with SCRT followed by chemotherapy | EXPERIMENTAL | Participants will receive QD doses of E7046 (RP2D determined in the Dose-Escalation part of the study) for 10 weeks, starting on Day 1, 14 days prior to initiation of the radiotherapy. Short course radiotherapy (SCRT) will be initiated on Day 15 and will consist of a total of 25 Gy radiation administered in 5 Gy daily doses for 5 days (Monday to Friday) for 1 week. Ten days after the end of radiotherapy, 3 cycles of the modified folinic acid/5-FU/oxaliplatin (mFOLFOX-6) regimen will be administered every 2 weeks for 2 consecutive days. Surgery will be performed 14 to 16 weeks from the first day of E7046 treatment. |
| Name | Type | Description |
|---|---|---|
| E7046 | DRUG | oral administration |
| Long Course Chemoradiotherapy (LCRT) | RADIATION | pelvic radiotherapy |
| Short Course Radiotherapy (SCRT) | RADIATION | pelvic radiotherapy |
| capecitabine | DRUG | chemotherapy |
| folinic acid/5-FU/oxaliplatin (mFOLFOX-6) | DRUG | chemotherapy |
Inclusion Criteria: * Diagnosis of histologically confirmed invasive primary rectal carcinoma * Age ≥18 years at the time of informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Participants must have locally advanced rectum cancer where primary resection with...