NCT01576380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

April 2, 2012

Last Update Submit

February 23, 2017

Conditions

Adenocarcinoma, ScirrhousLinitis PlasticaStomach NeoplasmsStomach DiseasesNeoplasms by SiteNeoplasms

Keywords

Solid tumorsAdvanced scirrhous gastric carcinomaGastric CancerSecond-line or third-line treatmentVEGFFGFRNeoplasmsGastric NeoplasmsCancerCarcinomaGastric DiseasesFemale Genital DiseasesTumorsOral AdministrationCapsulesTKI258TKI-258TKI 258

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • time to progression (TTP)

    baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression

  • overall response rate (ORR)

    baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress

  • progression free survival (PFS)

    baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress

  • overall survival (OS)

    every 8 weeks until death

  • disease control rate (DCR) per independent central review

    up to 8 weeks after the start date of study treatment

  • +5 more secondary outcomes

Study Arms (1)

TKI258

EXPERIMENTAL

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

Interventions

TKI258DRUG

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.

Also known as: Dovitinib
TKI258

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative Site

Nagoya, Aichi-ken, 464-8681, Japan

Location

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Novartis Investigative Site

Matsuyama, Ehime, 791-0280, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Novartis Investigative Site

Takatsuki, Osaka, 569-8686, Japan

Location

Novartis Investigative Site

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Novartis Investigative Site

Chuo-ku, Tokyo, 104-0045, Japan

Location

Novartis Investigative Site

Koto, Tokyo, 135-8550, Japan

Location

MeSH Terms

Conditions

Adenocarcinoma, ScirrhousLinitis PlasticaStomach NeoplasmsStomach DiseasesNeoplasms by SiteNeoplasmsCarcinomaGenital Diseases, Female

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2012

First Posted

April 12, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

JP(8)