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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02688712 | ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 50 | — | — | Mar 24, 2016 | Dec 1, 2026 | Apr 13, 2026 | 1 | United States |
Complete response is defined as no viable tumor cells identified.
| Arm | Type | Description |
|---|---|---|
| LY2157299 + Chemoradiation + Surgery | EXPERIMENTAL | Patients will receive a 14 day course of LY2157299. On day 15 patients will begin chemoradiation treatment with Capecitabine or Fluorouracil. On day 29, patients will undergo another fourteen day course of LY2157299 concurrent with their ongoing chemoradiation treatment. Six to ten weeks after completing their neoadjuvant therapy, patient will undergo a tumor specific mesorectal excision as per standard of care. |
| Name | Type | Description |
|---|---|---|
| LY2157299 | DRUG | Small molecule inhibitor of transforming growth factor-beta signaling pathway |
| Capecitabine | DRUG | Antimetabolite chemotherapy |
| Fluorouracil | DRUG | Antimetabolite chemotherapy |
| Tumor specific mesorectal excision | PROCEDURE | Tumor specific mesorectal excision |
Inclusion Criteria: * Patients (male and female) with histologically confirmed rectal adenocarcinoma, AJCC Stage IIA-IIIC or AJCC Stage IV appropriate for consideration of primary rectal tumor resection. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Age 18 years or above. * L...