Clinical trial NCT04071184: Study of Alofanib in Patients With Metastatic Gastric Cancer
Official title: Phase 1b Clinical Study of the Safety and Pharmacokinetics of Alofanib in Patients With Metastatic Gastric Cancer Resistant to Standard Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastric Cancer
Keywords: gastric cancer
metastases
patients with previous treatment failures
FGFR2 abnormalities
Lead sponsor: Russian Pharmaceutical Technologies
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum tolerated dose (MTD) or Recommended phase 2 dose (RP2D)
timeFrame: 6 months
Secondary outcomes:
measure: Cmax
timeFrame: 1 month
measure: Tmax
timeFrame: 1 month
measure: AUC
timeFrame: 1 month
measure: t1/2
timeFrame: 1 month
measure: CL
timeFrame: 1 month
measure: Vd
timeFrame: 1 month
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: 12 months
measure: Progression-free survival (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 12 months
measure: Objective response rate (ORR)
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N.N.Blokhin Russian Cancer Research Centre, Dept. of Clinical Pharmacology and Chemotherapy
city: Omsk
country: Russian Federation
facility: Omsk Regional Cancer Center
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Research Institute of Oncology
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg City Cancer Center
Study officials:
affiliation: Scientific Adviser
name: Ilya Tsimafeyeu, MD
role: STUDY_DIRECTOR
References: