Clinical trial · Interventional
A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients
A Single-arm, Multi-center, Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Adult Patients With Advanced Scirrhous Gastric Carcinoma That Have Progressed After One or Two Prior Systemic Treatments
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or two prior systemic treatments.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma, Scirrhous | Scirrhous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Linitis Plastica | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Stomach Diseases | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TKI258 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TKI258
- description
- 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.
- interventionNames
- Drug: TKI258
Primary outcomes (1)
- measure
- disease control rate (DCR)
- timeFrame
- up to 8 weeks after the start date of study treatment
- description
- 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.
Secondary outcomes (10)
- measure
- time to progression (TTP)
- timeFrame
- baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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 progression * ECOG performance status of 0 to 2 * Male and female patients aged 20 years or greater * Adequate liver, renal, and hematologic function Exclusion Criteria: * Patients who received prior treatment with an FGFR inhibitor * Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases * Patients with another primary malignancy within 3 years prior to starting study treatment Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available