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

February 23, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Novartis Investigative Site
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo-city, Hokkaido, Japan, 060-8648
        • Novartis Investigative Site
    • Osaka
      • Takatsuki, Osaka, Japan, 569-8686
        • Novartis Investigative Site
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Novartis Investigative Site
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Novartis Investigative Site
      • Koto, Tokyo, Japan, 135-8550
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TKI258
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.
Drug: TKI258
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.
Other Names:
  • Dovitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease control rate (DCR)
Time Frame: up to 8 weeks after the start date of study treatment
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.
up to 8 weeks after the start date of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to progression (TTP)
Time Frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression
TTP is defined as the time from the start date of study treatment to the date of event defined as the first documented progression or death due to underlying cancer as per local investigator's assessment.
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression
overall response rate (ORR)
Time Frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
ORR is defined as the proportion of patients with best overall response of CR or PR as per local investigator's assessment.
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
progression free survival (PFS)
Time Frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
PFS is defined as the time from the start date of study treatment to the date of event defined as the first documented progression or death due to any cause as per local investigator's assessment.
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
overall survival (OS)
Time Frame: every 8 weeks until death
OS is defined as the time from the start date of study treatment to the date of death from any cause.
every 8 weeks until death
disease control rate (DCR) per independent central review
Time Frame: up to 8 weeks after the start date of study treatment
Eight-week DCR is as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.
up to 8 weeks after the start date of study treatment
time to progression (TTP) per independent central review
Time Frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
TTP as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Safety and tolerability of TKI258
Time Frame: more than 30 days after the last date of study treatment
Safety will be measured in terms of type, frequency and severity of adverse events according to CTCAE v4.03.
more than 30 days after the last date of study treatment
Plasma concentrations of TKI258
Time Frame: 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)
Pharmacokinetics (PK) of TKI258 at each scheduled time point of single dose and steady dose.
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)
overall response rate (ORR) per independent central review
Time Frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
ORR as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
progression free survival (PFS) per independent central review
Time Frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
PFS as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimate)

April 12, 2012

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTKI258A1201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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