Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CHIR-258, receptor tyrosine kinase inhibitor TKI258, RTK inhibitor TKI258, TKI258
dovitinib lactate · 13 trials · 25 indications
Eight-week DCR is defined as the proportion of patients with best overall response of CR, PR or SD at the end of Week 8 as per local investigator's assessment.
The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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 |
|---|---|---|
| TKI258 | EXPERIMENTAL | TKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week. |
| FGFR3 wild type | EXPERIMENTAL | - |
| FGFR3 mutant | EXPERIMENTAL | - |
| TKI258 - Positive | EXPERIMENTAL | These are the participants who had a positive T(4;14) status |
| TKI258 - Negative | EXPERIMENTAL | These are the participants who had a negative T(4;14) status |
| TKI258 Non-interpretable | EXPERIMENTAL | These are the participants who had a non-interpretable T(4;14) status |
| 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. |
| 500 mg FMI capsule + 250 mg FMI tablet | EXPERIMENTAL | BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet |
| 500 mg TKI258 FMI capsule +250 mg FMI tablet | EXPERIMENTAL | BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule |
| Arm 1 - TKI258 - bioavailability | EXPERIMENTAL | - |
| TKI258 - food effect | EXPERIMENTAL | - |
| TKI258 - bioavailability | EXPERIMENTAL | - |
| TKI258 - food | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TKI258 | DRUG | TKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week. |
| 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 |
| TKI258 (dovitinib) | DRUG | bioavailability (anhydrate capsules) food (monohydrae capsules) |
Inclusion Criteria: * Diagnosis of advanced/metastatic scirrhous gastric carcinoma * Evidence of diffusely infiltrating gastric lesions and/or at least one measurable extra-gastric lesion * Patients previously treated with one or two systemic lines * Documented radiological confirmation of disease ...
Dovitinib lactate is an investigational small molecule being studied in oncology, specifically for adenocarcinoma of the pancreas, including stage III and stage IV pancreatic cancer, as well as biliary cancers and advanced or metastatic solid tumors. It is not approved for any indication and remains in clinical development.
Dovitinib lactate is a multi-kinase inhibitor that targets FGFR3, PDGFRB, PDGFRA, KIT, FLT3, and FLT1. By inhibiting these receptor tyrosine kinases, it is designed to interfere with signaling pathways involved in tumor cell proliferation, angiogenesis, and survival.
Dovitinib lactate is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the drug in pancreatic cancer and other solid tumors.
Dovitinib lactate is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 1 trial has been completed, and no active trials are currently listed for this asset.
Dovitinib lactate has been evaluated in one completed Phase 1 trial, NCT01497392, which studied dovitinib lactate with gemcitabine hydrochloride and capecitabine in patients with advanced or metastatic solid tumors, pancreatic cancer, and biliary cancers. The trial enrolled 26 patients in the United States.