None listed
Conditions
Interventions
Drug : * Phase I: Lenvatinib dose will be determined using a standard 3+3 dose-escalation design (see table below).
* Phase II: Capecitabine 1,000 mg/m² twice daily (BID
administered for 2 weeks followed by 1 week off) in combination with lenvatinib at the dose determined in Phase I, administered once daily (QD), in 3-week cycles.
Dose Level Table (Phase I)
Capecitab
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Voluntarily signed written informed consent 2) Male or female =19 years of age 3) Histologically confirmed metastatic or unresectable colorectal adenocarcinoma 4) Metastatic colorectal cancer refractory to irinotecan, oxaliplatin, and fluoropyrimidines 5) ECOG performance status 0, 1, or 2 6) Measurable lesion per RECIST v1.1 7) Hemoglobin =9.0 g/dL, ANC =1,500/µL, Platelets =100,000/µL, Serum creatinine <1.5×ULN, AST/ALT <3×ULN, Total bilirubin <1.5×ULN (all without transfusion or G-CSF within 14 days of screening) 8) Able to understand and comply with the study protocol through completion 9) Women of childbearing potential: negative pregnancy test within 14 days before first dose; agreement to use adequate contraception for =6 months after last dose 10) Men with pregnant or potentially pregnant partners: agreement to use adequate contraception (e.g., condom) for =3 months after last dose
Exclusion criteria
Exclusion criteria: 1) Pregnant or breastfeeding women 2) History of another malignancy within the past 5 years (except papillary or follicular thyroid cancer) 3) Uncontrolled infection or other systemic diseases 4) Known hypersensitivity to the investigational drugs 5) Presence of bowel stent or biliary stent with risk of perforation or bleeding 6) Esophageal/gastric varices or other risk of gastrointestinal hemorrhage 7) Significant uncontrolled concurrent illness (cardiovascular, hypertension, thromboembolic disorders) 8) Uncontrolled proteinuria (3+ or higher on spot urinalysis; 2+ acceptable only if U/PCR =1 g/Cr) 9) QTcF >480 msec 10) Known DPD (dihydropyrimidine dehydrogenase) deficiency 11) Active CNS metastases and/or carcinomatous meningitis 12) Judged ineligible by the investigator 13) Major surgery within 1 month prior to enrollment 14) Receipt of another investigational drug within 4 weeks prior to enrollment or currently enrolled in another clinical trial 15) Requiring concurrent systemic anticancer therapy during the study 16) Currently receiving prohibited concomitant medications (e.g., sorivudine and analogues, allopurinol) that cannot be discontinued before first dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS) by RECIST v1.1;Disease Control Rate (DCR);Duration of Response (DOR) | — |
Countries
Korea, Republic of
Contacts
Public Contactsun A Han
Seoul National University Bundang Hospital
Outcome results
None listed