A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients

Novartis

Status and phase

Completed

Phase 2

Conditions

Linitis Plastica

Neoplasms

Neoplasms by Site

Stomach Diseases

Adenocarcinoma, Scirrhous

Stomach Neoplasms

Treatments

Drug: TKI258

Study type

Interventional

Funder types

Industry

Identifiers

NCT01576380

CTKI258A1201

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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