Clinical trial NCT01576380: A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma, Scirrhous
Linitis Plastica
Stomach Neoplasms
Stomach Diseases
Neoplasms by Site
Neoplasms
Keywords: 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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-04-12
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: disease control rate (DCR)
timeFrame: up to 8 weeks after the start date of study treatment
Secondary outcomes:
measure: time to progression (TTP)
timeFrame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression
measure: overall response rate (ORR)
timeFrame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
measure: progression free survival (PFS)
timeFrame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
measure: overall survival (OS)
timeFrame: every 8 weeks until death
measure: disease control rate (DCR) per independent central review
timeFrame: up to 8 weeks after the start date of study treatment
measure: time to progression (TTP) per independent central review
timeFrame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
measure: Safety and tolerability of TKI258
timeFrame: more than 30 days after the last date of study treatment
measure: Plasma concentrations of TKI258
timeFrame: Week 1 Day 1 - Day 2: pre-dose (0 hour), 1, 2, 4, 6, 8, and 24 hour (pre-dose). and Week 4 Day 5 - Week 5 Day 1: pre-dose (0 hour), 1, 2, 4, 6, 8, 24, 48, and 72 hour (pre-dose)
measure: overall response rate (ORR) per independent central review
timeFrame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
measure: progression free survival (PFS) per independent central review
timeFrame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sunto-gun
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: