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Study of Alofanib in Patients With Metastatic Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Alofanib
Sponsored by
Russian Pharmaceutical Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, metastases, patients with previous treatment failures, FGFR2 abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • N.N.Blokhin Russian Cancer Research Centre, Dept. of Clinical Pharmacology and Chemotherapy
  • Omsk Regional Cancer CenterRecruiting
  • Rostov Research Institute of Oncology
  • St. Petersburg City Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose cohorts

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cmax
Peak Plasma Concentration (Cmax), the maximum concentration recorded
Tmax
Time of Maximum concentration observed
AUC
Area under the plasma concentration versus time curve
t1/2
Elimination half-life, the time taken for the plasma concentration to fall by half its original value
CL
blood clearance
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
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
Progression-free survival (PFS)
PFS is defined as the time from treatment start to disease progression or death from any cause
Overall survival (OS)
OS is defined as the time from treatment start to death from any cause
Objective response rate (ORR)
ORR is the proportion of patients with tumor size reduction.

Full Information

First Posted
August 13, 2019
Last Updated
September 25, 2019
Sponsor
Russian Pharmaceutical Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT04071184
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 26, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Russian Pharmaceutical Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, metastases, patients with previous treatment failures, FGFR2 abnormalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose cohorts
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Alofanib
Intervention Description
Five dose cohorts and expanded cohort will be included
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) or Recommended phase 2 dose (RP2D)
Description
The highest dose of an alofanib that does not cause unacceptable side effects and recommended
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cmax
Description
Peak Plasma Concentration (Cmax), the maximum concentration recorded
Time Frame
1 month
Title
Tmax
Description
Time of Maximum concentration observed
Time Frame
1 month
Title
AUC
Description
Area under the plasma concentration versus time curve
Time Frame
1 month
Title
t1/2
Description
Elimination half-life, the time taken for the plasma concentration to fall by half its original value
Time Frame
1 month
Title
CL
Description
blood clearance
Time Frame
1 month
Title
Vd
Description
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
Time Frame
1 month
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
Rate of AEs and SAEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
12 months
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from treatment start to disease progression or death from any cause
Time Frame
12 months
Title
Overall survival (OS)
Description
OS is defined as the time from treatment start to death from any cause
Time Frame
12 months
Title
Objective response rate (ORR)
Description
ORR is the proportion of patients with tumor size reduction.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilya Tsimafeyeu, MD
Phone
+79265646581
Email
office@ruspharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilya Tsimafeyeu, MD
Organizational Affiliation
Scientific Adviser
Official's Role
Study Director
Facility Information:
Facility Name
N.N.Blokhin Russian Cancer Research Centre, Dept. of Clinical Pharmacology and Chemotherapy
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Omsk Regional Cancer Center
City
Omsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galina B Statsenko, MD
Phone
+7 (3812) 60-19-07
First Name & Middle Initial & Last Name & Degree
Galina B Statsenko, MD
Facility Name
Rostov Research Institute of Oncology
City
Rostov-on-Don
Country
Russian Federation
Individual Site Status
Enrolling by invitation
Facility Name
St. Petersburg City Cancer Center
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of Alofanib in Patients With Metastatic Gastric Cancer

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