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
20 Years
N/A
Both
Adenocarcinoma, Scirrhous,, Linitis Plastica, Stomach Neoplasms,, Stomach Diseases,, Neoplasms by Site, Neoplasms
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease control rate (DCR)
Outcome 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.
Outcome Time Frame:
up to 8 weeks after the start date of study treatment
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
CTKI258A1201
NCT ID:
NCT01576380
Start Date:
June 2012
Completion Date:
November 2014
Related Keywords:
- Adenocarcinoma, Scirrhous,
- Linitis Plastica
- Stomach Neoplasms,
- Stomach Diseases,
- Neoplasms by Site
- Neoplasms
- Solid tumors,
- Advanced scirrhous gastric carcinoma,
- Gastric Cancer,
- Second-line or third-line treatment,
- VEGF,
- FGFR,
- Neoplasms,
- Gastric Neoplasms,
- Cancer,
- Carcinoma,
- Gastric Diseases,
- Female Genital Diseases,
- Tumors,
- Oral Administration,
- Capsules,
- TKI258,
- TKI-258,
- TKI 258
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Neoplasms
- Carcinoma
- Adenocarcinoma, Scirrhous
- Linitis Plastica
- Stomach Neoplasms
- Neoplasms by Site
- Stomach Diseases
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