Study of Alofanib in Patients With Metastatic Gastric Cancer

NCT ID: NCT04071184

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-26
• Study Completion Date: 2020-12-01

Brief 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose cohorts

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.

Group Type: EXPERIMENTAL

Alofanib

Intervention Type: DRUG

Five dose cohorts and expanded cohort will be included

Interventions

Alofanib

Five dose cohorts and expanded cohort will be included

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian Pharmaceutical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilya Tsimafeyeu, MD

Role: STUDY_DIRECTOR

Scientific Adviser

Locations

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

Moscow, , Russia

Site Status: ACTIVE_NOT_RECRUITING

Omsk Regional Cancer Center

Omsk, , Russia

Site Status: RECRUITING

Rostov Research Institute of Oncology

Rostov-on-Don, , Russia

Site Status: ENROLLING_BY_INVITATION

St. Petersburg City Cancer Center

Saint Petersburg, , Russia

Site Status: ACTIVE_NOT_RECRUITING

Countries

Russia

Central Contacts

Ilya Tsimafeyeu, MD

Role: CONTACT

office@ruspharm.com

+79265646581

Facility Contacts

Galina B Statsenko, MD

Role: primary

+7 (3812) 60-19-07

References

Tsimafeyeu I, Statsenko G, Vladimirova L, Besova N, Artamonova E, Raskin G, Rykov I, Mochalova A, Utyashev I, Gorbacheva S, Kazey V, Gavrilova E, Dragun N, Moiseyenko V, Tjulandin S. A phase 1b study of the allosteric extracellular FGFR2 inhibitor alofanib in patients with pretreated advanced gastric cancer. Invest New Drugs. 2023 Apr;41(2):324-332. doi: 10.1007/s10637-023-01340-z. Epub 2023 Mar 13.

Reference Type: DERIVED

PMID: 36907947 (View on PubMed)

Other Identifiers

RPT835GC1B

Identifier Type: -

Identifier Source: org_study_id