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Completed

NCT Number: NCT01576380

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

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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Key information

Conditions

Adenocarcinoma, Scirrhous Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Linitis Plastica Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Stomach Diseases Stomach Neoplasms Urogenital Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TKI258

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.

Other names: Dovitinib

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 12, 2012
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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