Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TKI258 · 12 trials · 21 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.
| 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 |
| 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. |
| 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 ...
TKI258 is an investigational small molecule being studied for the treatment of advanced solid tumors, neoplasms, melanoma, adenocarcinoma, scirrhous, advanced solid malignancies, and advanced or metastatic renal cell cancer. It has also been evaluated in clinical trials for urothelial carcinoma and endometrial cancer.
TKI258 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development for oncology indications.
TKI258 is in Phase 2 clinical development. It has completed two Phase 2 trials and two Phase 1 trials. The drug is investigational and has not been approved by regulatory authorities for any indication.
TKI258 has completed four clinical trials. NCT00790426 was a Phase 2 study in advanced urothelial carcinoma with 44 participants. NCT01379534 was a Phase 2 study in FGFR2 mutated or wild-type advanced or metastatic endometrial cancer with 53 participants. NCT01421004 and NCT01471548 were Phase 1 studies in advanced solid tumors.
TKI258 is a small molecule that targets fibroblast growth factor receptors (FGFR), as indicated by its evaluation in patients with FGFR2 mutations. It is being studied in cancers where FGFR signaling may play a role in tumor growth and progression.
TKI258 is also known by the generic name dovitinib. It is a multi-targeted receptor tyrosine kinase inhibitor being developed by Novartis. No other alternative names have been established for this compound in clinical development.