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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01497392 | Dovitinib Lactate, Gemcitabine Hydrochloride, and Capecitabine in Treating Patients With Advanced or Metastatic Solid Tumors, Pancreatic Cancer and Biliary Cancers | PHASE1 | COMPLETED | 26 | — | — | Mar 29, 2012 | Feb 7, 2017 | Jul 22, 2022 | 1 | United States |
All toxicities and adverse events will be summarized with frequencies and descriptive measures, and tabulated according to body system, severity and relation to treatment.
All toxicities and adverse events will be summarized with frequencies and descriptive measures, and tabulated according to body system, severity and relation to treatment.
| Arm | Type | Description |
|---|---|---|
| Treatment (dovitinib lactate, gemcitabine, and capecitabine) | EXPERIMENTAL | Patients receive dovitinib lactate PO on days 1-5, 8-12, and 15-19, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and capecitabine PO twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| dovitinib lactate | DRUG | Given PO |
| gemcitabine hydrochloride | DRUG | Given IV |
| capecitabine | DRUG | Given PO |
| laboratory biomarker analysis | OTHER | Correlative studies |
| enzyme-linked immunosorbent assay | OTHER | Correlative studies |
| pharmacological study | OTHER | Correlative studies |
Inclusion Criteria: * Part A: histologically or cytologically confirmed solid tumors that ale advanced or metastatic that the gemcitabine combination is considered standard therapy or a rational option * Part B: histologically or cytologically confirmed adenocarcinoma of the pancreas or the biliary...