NCT04071184

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 gastric-cancer

Timeline
Completed

Started May 2019

Shorter than P25 for phase_1 gastric-cancer

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

August 13, 2019

Last Update Submit

September 25, 2019

Conditions

Gastric Cancer

Keywords

gastric cancermetastasespatients with previous treatment failuresFGFR2 abnormalities

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Cmax

    1 month

  • Tmax

    1 month

  • AUC

    1 month

  • t1/2

    1 month

  • CL

    1 month

  • +5 more secondary outcomes

Study Arms (1)

Dose cohorts

EXPERIMENTAL

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.

Drug: Alofanib

Interventions

AlofanibDRUG

Five dose cohorts and expanded cohort will be included

Dose cohorts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Moscow, 115478, Russia

ACTIVE NOT RECRUITING

Omsk Regional Cancer Center

Omsk, Russia

RECRUITING

Rostov Research Institute of Oncology

Rostov-on-Don, Russia

ENROLLING BY INVITATION

St. Petersburg City Cancer Center

Saint Petersburg, Russia

ACTIVE NOT RECRUITING

Related Publications (1)

  • 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.

    PMID: 36907947DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Interventions

alofanib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ilya Tsimafeyeu, MD

    Scientific Adviser

    STUDY DIRECTOR

Central Study Contacts

Ilya Tsimafeyeu, MD

CONTACT

+79265646581office@ruspharm.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 28, 2019

Study Start

May 26, 2019

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

RU(4)