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

Primary Purpose

Adenocarcinoma, Scirrhous, Linitis Plastica, Stomach Neoplasms

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
TKI258
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma, Scirrhous focused on measuring 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

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TKI258

Arm 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.

Outcomes

Primary Outcome Measures

disease control rate (DCR)
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 Outcome Measures

time to progression (TTP)
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.
overall response rate (ORR)
ORR is defined as the proportion of patients with best overall response of CR or PR as per local investigator's assessment.
progression free survival (PFS)
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.
overall survival (OS)
OS is defined as the time from the start date of study treatment to the date of death from any cause.
disease control rate (DCR) per independent central review
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.
time to progression (TTP) per independent central review
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.
Safety and tolerability of TKI258
Safety will be measured in terms of type, frequency and severity of adverse events according to CTCAE v4.03.
Plasma concentrations of TKI258
Pharmacokinetics (PK) of TKI258 at each scheduled time point of single dose and steady dose.
overall response rate (ORR) per independent central review
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.
progression free survival (PFS) per independent central review
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.

Full Information

First Posted
April 2, 2012
Last Updated
February 23, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01576380
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TKI258
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
TKI258
Other Intervention Name(s)
Dovitinib
Intervention 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.
Primary Outcome Measure Information:
Title
disease control rate (DCR)
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.
Time Frame
up to 8 weeks after the start date of study treatment
Secondary Outcome Measure Information:
Title
time to progression (TTP)
Description
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.
Time Frame
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression
Title
overall response rate (ORR)
Description
ORR is defined as the proportion of patients with best overall response of CR or PR as per local investigator's assessment.
Time Frame
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Title
progression free survival (PFS)
Description
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.
Time Frame
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Title
overall survival (OS)
Description
OS is defined as the time from the start date of study treatment to the date of death from any cause.
Time Frame
every 8 weeks until death
Title
disease control rate (DCR) per independent central review
Description
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.
Time Frame
up to 8 weeks after the start date of study treatment
Title
time to progression (TTP) per independent central review
Description
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.
Time Frame
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Title
Safety and tolerability of TKI258
Description
Safety will be measured in terms of type, frequency and severity of adverse events according to CTCAE v4.03.
Time Frame
more than 30 days after the last date of study treatment
Title
Plasma concentrations of TKI258
Description
Pharmacokinetics (PK) of TKI258 at each scheduled time point of single dose and steady dose.
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)
Title
overall response rate (ORR) per independent central review
Description
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.
Time Frame
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Title
progression free survival (PFS) per independent central review
Description
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.
Time Frame
baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Novartis Investigative Site
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Novartis Investigative Site
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Novartis Investigative Site
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Novartis Investigative Site
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Novartis Investigative Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Novartis Investigative Site
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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