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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01576380
First received: April 2, 2012
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Adenocarcinoma, Scirrhous Linitis Plastica Stomach Neoplasms Stomach Diseases Neoplasms by Site Neoplasms Drug: TKI258 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 11
Study Start Date: June 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Dovitinib

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576380

Locations
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 464-8681
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Matsuyama, Ehime, Japan, 791-0280
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site
Takatsuki, Osaka, Japan, 569-8686
Novartis Investigative Site
Sunto-gun, Shizuoka, Japan, 411-8777
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 104-0045
Novartis Investigative Site
Koto, Tokyo, Japan, 135-8550
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01576380     History of Changes
Other Study ID Numbers: CTKI258A1201
Study First Received: April 2, 2012
Last Updated: February 23, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Adenocarcinoma
Stomach Neoplasms
Neoplasms by Site
Stomach Diseases
Linitis Plastica
Adenocarcinoma, Scirrhous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 28, 2017