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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TKI258

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Dovitinib

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No