A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients
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ClinicalTrials.gov Identifier: NCT01576380 |
Recruitment Status
:
Completed
First Posted
: April 12, 2012
Last Update Posted
: February 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenocarcinoma, Scirrhous Linitis Plastica Stomach Neoplasms Stomach Diseases Neoplasms by Site Neoplasms | Drug: TKI258 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
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 |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

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.
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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
|
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576380
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Additional Information:
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01576380 History of Changes |
Other Study ID Numbers: |
CTKI258A1201 |
First Posted: | April 12, 2012 Key Record Dates |
Last Update Posted: | February 27, 2017 |
Last Verified: | February 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 |