Study of Alofanib in Patients With Metastatic Gastric Cancer

Russian Pharmaceutical Technologies

Status and phase: Unknown; Phase 1

Conditions: Gastric Cancer

Treatments: Drug: Alofanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04071184

RPT835GC1B

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Dose cohorts

Experimental group

Description:

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.

Treatment:

Drug: Alofanib