Status:
UNKNOWN
Study of Alofanib in Patients With Metastatic Gastric Cancer
Lead Sponsor:
Russian Pharmaceutical Technologies
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 facto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04071184
Start Date
May 26 2019
End Date
December 1 2020
Last Update
September 26 2019
Active Locations (4)
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1
N.N.Blokhin Russian Cancer Research Centre, Dept. of Clinical Pharmacology and Chemotherapy
Moscow, Russia, 115478
2
Omsk Regional Cancer Center
Omsk, Russia
3
Rostov Research Institute of Oncology
Rostov-on-Don, Russia
4
St. Petersburg City Cancer Center
Saint Petersburg, Russia