TKI258

Novartis Pharmaceuticals

This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.

Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors

A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258 (CSF Capsule vs. FMI Tablet), and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors

Neoplasms

All Conditions

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Adenocarcinoma

Stomach Neoplasms

Genital Diseases, Female

Stomach Diseases

Genital Diseases

Adenocarcinoma, Scirrhous

Linitis Plastica

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Cancer

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.

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.

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

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

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.

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.

ORR is defined as the proportion of patients with best overall response of CR or PR as per local investigator's assessment.

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.

OS is defined as the time from the start date of study treatment to the date of death from any cause.

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.

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 will be measured in terms of type, frequency and severity of adverse events according to CTCAE v4.03.

Pharmacokinetics (PK) of TKI258 at each scheduled time point of single dose and steady dose.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors	NCT01155713	Neoplasm Cancer Tumors	TKI258	18 Years -	Novartis
A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients	NCT01576380	Adenocarcinoma,... Linitis Plastic... Stomach Neoplas... Stomach Disease... Neoplasms by Si... Neoplasms	TKI258	20 Years -	Novartis
A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients	NCT01576380	Adenocarcinoma,... Linitis Plastic... Stomach Neoplas... Stomach Disease... Neoplasms by Si... Neoplasms	TKI258	20 Years -	Novartis

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Spots Global Cancer Trial Database for capsules

Every month we try and update this database with for capsules cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for capsules cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.