Gastric CancerPhase 1NCT04071184
Study of Alofanib in Patients With Metastatic Gastric Cancer
A Phase 1 study testing Alofanib in people with Gastric Cancer, run by Russian Pharmaceutical Technologies at 4 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Alofanib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesRussia
- Study dates
- 26 May 2019to 1 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Russia4 sites, 2 recruiting
- Active, not recruiting
N.N.Blokhin Russian Cancer Research Centre, Dept. of Clinical Pharmacology and Chemotherapy
Moscow, 115478
- Recruiting
Omsk Regional Cancer Center
Omsk
Galina B Statsenko, MD, +7 (3812) 60-19-07
Galina B Statsenko, MD
- Enrolling by invitation
Rostov Research Institute of Oncology
Rostov-on-Don
- Active, not recruiting
St. Petersburg City Cancer Center
Saint Petersburg
About this study
Official title: Phase 1b Clinical Study of the Safety and Pharmacokinetics of Alofanib in Patients With Metastatic Gastric Cancer Resistant to Standard Therapy
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.
- Conditions
- Gastric Cancer
- Being tested
- Alofanib
- Keywords
- gastric cancer, metastases, patients with previous treatment failures, FGFR2 abnormalities
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlofanibDrug
Five dose cohorts and expanded cohort will be included
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Alofanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (10)
Cmax
Peak Plasma Concentration (Cmax), the maximum concentration recorded
Measured: 1 month
Tmax
Time of Maximum concentration observed
Measured: 1 month
AUC
Area under the plasma concentration versus time curve
Measured: 1 month
t1/2
Elimination half-life, the time taken for the plasma concentration to fall by half its original value
Measured: 1 month
CL
blood clearance
Measured: 1 month
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
Measured: 1 month
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
Measured: 12 months
Progression-free survival (PFS)
PFS is defined as the time from treatment start to disease progression or death from any cause
Measured: 12 months
Overall survival (OS)
OS is defined as the time from treatment start to death from any cause
Measured: 12 months
Objective response rate (ORR)
ORR is the proportion of patients with tumor size reduction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 May 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Pharmaceutical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilya Tsimafeyeu, MD, Study director, Scientific Adviser
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071184
- Sponsor's protocol ID
- RPT835GC1B
- Status last verified
- Sep 2019
- First submitted
- 13 Aug 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36907947
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Clinical Study of the Safety and Pharmacokinetics of Alofanib in Patients With Metastatic Gastric Cancer Resistant to Standard Therapy
- ClinicalTrials.gov ID
- NCT04071184
- Acronym / sponsor ID
- RPT835GC1B
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, metastases, patients with previous treatment failures, FGFR2 abnormalities
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Russian Pharmaceutical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 26 May 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose cohorts | Experimental | Drug: AlofanibPart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlofanibFive dose cohorts and expanded cohort will be included | Drug | Dose cohorts |
Primary outcome
Maximum tolerated dose (MTD) or Recommended phase 2 dose (RP2D)
Time frame: 6 months
The highest dose of an alofanib that does not cause unacceptable side effects and recommended
10 secondary outcomes
Cmax
Time frame: 1 month
Tmax
Time frame: 1 month
AUC
Time frame: 1 month
t1/2
Time frame: 1 month
CL
Time frame: 1 month
Vd
Time frame: 1 month
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: 12 months
Progression-free survival (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Objective response rate (ORR)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Derived from this study: PubMed 36907947Tsimafeyeu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Tsimafeyeu, MD study director
Scientific Adviser
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alofanib in people with Gastric Cancer, run by Russian Pharmaceutical Technologies at 4 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilya Tsimafeyeu, MD (+79265646581, office@ruspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) or Recommended phase 2 dose (RP2D) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04071184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.