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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576380
• Other study ID #: CTKI258A1201
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2012
• Last updated: February 23, 2017
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Scirrhous
• Carcinoma
• Linitis Plastica
• Neoplasms
• Neoplasms by Site
• Stomach Diseases
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Koto	Tokyo
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sunto-gun	Shizuoka
Japan	Novartis Investigative Site	Takatsuki	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 8 weeks after the start date of study treatment
Secondary	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.	baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression
Secondary	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.	baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Secondary	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.	baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Secondary	overall survival (OS)	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
Secondary	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.	up to 8 weeks after the start date of study treatment
Secondary	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.	baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Secondary	Safety and tolerability of TKI258	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
Secondary	Plasma concentrations of TKI258	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)
Secondary	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.	baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Secondary	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.	baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress

External Links

•   Results for CTKI258A1201 from the Novartis Clinical Trials website