Study of Alofanib in Patients With Metastatic Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071184
• Other study ID #: RPT835GC1B
• Status: Recruiting
• Phase: Phase 1
• Start date: May 26, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2019
• Source: Russian Pharmaceutical Technologies
• Contact: Ilya Tsimafeyeu, MD
• Phone: +79265646581
• Email: office[@]ruspharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Alofanib
Five dose cohorts and expanded cohort will be included

Locations

Country	Name	City	State
Russian Federation	N.N.Blokhin Russian Cancer Research Centre, Dept. of Clinical Pharmacology and Chemotherapy	Moscow
Russian Federation	Omsk Regional Cancer Center	Omsk
Russian Federation	Rostov Research Institute of Oncology	Rostov-on-Don
Russian Federation	St. Petersburg City Cancer Center	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Russian Pharmaceutical Technologies

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) or Recommended phase 2 dose (RP2D)	The highest dose of an alofanib that does not cause unacceptable side effects and recommended	6 months
Secondary	Cmax	Peak Plasma Concentration (Cmax), the maximum concentration recorded	1 month
Secondary	Tmax	Time of Maximum concentration observed	1 month
Secondary	AUC	Area under the plasma concentration versus time curve	1 month
Secondary	t1/2	Elimination half-life, the time taken for the plasma concentration to fall by half its original value	1 month
Secondary	CL	blood clearance	1 month
Secondary	Vd	Volume of distribution, the theoretical volume that would be necessary to contain the total amount of an alofanib at the same concentration that it is observed in the plasma	1 month
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	Rate of AEs and SAEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0	12 months
Secondary	Progression-free survival (PFS)	PFS is defined as the time from treatment start to disease progression or death from any cause	12 months
Secondary	Overall survival (OS)	OS is defined as the time from treatment start to death from any cause	12 months
Secondary	Objective response rate (ORR)	ORR is the proportion of patients with tumor size reduction.	12 months