Trial | NCT04071184  Report issue

Title

Study of Alofanib in Patients With Metastatic Gastric Cancer
Phase 1b Clinical Study of the Safety and Pharmacokinetics of Alofanib in Patients With Metastatic Gastric Cancer Resistant to Standard Therapy

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
Study Started
May 26
2019
Primary Completion
Oct 01
2020
Anticipated
Study Completion
Dec 01
2020
Anticipated
Last Update
Sep 26
2019

Drug Alofanib

Five dose cohorts and expanded cohort will be included

Dose cohorts Experimental

Part 1 (dose escalation): "3+3" design will be used. Alofanib (dose levels of 50, 100, 165, 250, 350 mg/m2) will be given i.v. daily (1-5 days on, 6-7 days off, every week) till progression or unacceptable toxicity. Part 2 (dose expansion): Afterwards the dosing regimen identified in Part 1 will be evaluated in a single-arm study focused on clinical efficacy.

Criteria 

Inclusion Criteria:

Histologically confirmed gastric cancer (adenocarcinoma)
Progression of the disease (clinical and/or radiological) on previous standard systemic 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 could potentially serve as obstacles to the implementation of the study
Patients capable of childbearing should use an effective method of contraception
Signed Informed Consent

Exclusion Criteria:

Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study
Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study
Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study
Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with 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 and C
Surgery within 7 days before the first dose of the study drug
Signs of bleeding or hemorrhagic diathesis
No Results Posted