ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer

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. * Laboratory values (performed within 28 days prior to enrollment) as follows: * WBC ≥3.0 109/L * Hgb ≥9g/dl (patients may be transfused to reach this level) * Platelets ≥99 109 /L * Creatinine ≤1.5X upper limit of laboratory normal * AST/ALT ≤5 X upper limit of laboratory normal * Total bilirubin ≤1.5X upper limit of laboratory normal * BNP ≤ 3 times the baseline value and upper limit of laboratory normal * Troponin I ≤ upper limit of laboratory normal * hsCRP ≤ upper limit of laboratory normal * Cystatin ≤ upper limit of laboratory normal * PT/INR ≤1.5X upper limit of laboratory normal * Pre-menopausal women must have a negative pregnancy test on the day treatment starts and must avoid becoming pregnant while on treatment and for 3 months following completion of therapy. Men must avoid fathering a child while on treatment and for 3 months following completion of therapy. This exclusion is required due to the toxicities that chemotherapy, radiation, and LY2157299 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may alter immune function it may limit the treatment efficacy. Women of childbearing potential must agree to…