Study of Alofanib in Patients With Metastatic Gastric Cancer

Last updated: September 25, 2019
Sponsor: Russian Pharmaceutical Technologies
Overall Status: Active - Recruiting

Phase

1

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT04071184
RPT835GC1B
  • Ages > 18
  • All Genders

Study Summary

This is a non-randomized multicenter phase 1b clinical trial of the safety and pharmacokinetics, as well as the preliminary efficacy of monotherapy with alofanib, an allosteric fibroblast growth factor receptor 2 inhibitor, in patients with advanced gastric cancer who have exhausted the resource of standard therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed gastric cancer (adenocarcinoma)

  • Progression of the disease (clinical and/or radiological) on previous standardsystemic therapy

  • Measurable lesions according to the RECIST 1.1 criteria

  • Possibility to assess the amplification of FGFR2, fusion of FGFR2 genes,overexpression of FGFR2, phosphorylation of FRS2

  • ECOG PS 0-2

  • Age >= 18 years old

  • Adequate function of organs

  • Absence of any psychological, family, social or geographical circumstances that couldpotentially serve as obstacles to the implementation of the study

  • Patients capable of childbearing should use an effective method of contraception

  • Signed Informed Consent

Exclusion

Exclusion Criteria:

  • Participation in another clinical study and concomitant treatment with any researchdrug or any study of antitumor therapy, including radiation, within 28 days beforeinclusion in this study

  • Presence of metastases in the central nervous system and / or carcinoma of themeninges at the time of inclusion in the study

  • Presence or history of present signs of any condition, therapy or laboratoryabnormalities that could limit the interpretation of the results of this study

  • Any malignant tumor within the previous 5 years, with the exception of adequatelycured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancerwith limited growth, subject to adequate control over the course of this disease

  • Pregnancy

  • Known positive status for human immunodeficiency virus (HIV) or active hapatitis B andC

  • Surgery within 7 days before the first dose of the study drug

  • Signs of bleeding or hemorrhagic diathesis

Study Design

Total Participants: 50
Study Start date:
May 26, 2019
Estimated Completion Date:
December 01, 2020

Connect with a study center

  • N.N.Blokhin Russian Cancer Research Centre, Dept. of Clinical Pharmacology and Chemotherapy

    Moscow, 115478
    Russian Federation

    Site Not Available

  • Omsk Regional Cancer Center

    Omsk,
    Russian Federation

    Active - Recruiting

  • Rostov Research Institute of Oncology

    Rostov-on-Don,
    Russian Federation

    Site Not Available

  • St. Petersburg City Cancer Center

    Saint Petersburg,
    Russian Federation

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.