Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, PaclitaxelPhase 1/2NCT05529667
Fibroblast Growth Factor (FGFs) / Fibroblast Growth Factor Receptor (FGFRs) Genetic as a Second-line Therapy for Recurrent / Progressive Gastric Cancer With INCB054828 and Paclitaxel a Study to Evaluate the Safety and Efficacy of Combination Therapy.
A Phase 1/2 study testing INCB054828, Paclitaxel in people with Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, Paclitaxel, run by Yonsei University at 1 site in South Korea.
Trial summary
This study was conducted as a second-line treatment of recurrent / progressive gastric cancer patients with FGFs / FGFRs genetic mutations in the Ib / II clinical trial. The maximum maximal tolerated dose (MTD) and 2-phase recommended dose in combination with INCB054828 and paclitaxel (recommended phase II dose… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, Paclitaxel
- What is being tested?
- INCB054828, Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2019to 30 Aug 2023
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agreed in writing to the clinical study consent
- Histologically or cytologically confirmed advanced gastric adenocarcinoma. Patients must have experienced objective radiological or disease progress with evidence during or after primary therapy with fluoropyrimidine and platinum.
- FGFs / FGFRs have genetic variation on NGS.
- Patients whose life expectancy is at least 3 months
- If the Eastern Cooperative Oncology Group (ECOG) is 0 or 1
- Measurable or assessable lesion based on RECIST 1.1 scale
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- Must be swallowed, should be able to take oral medication
- Possible long-term function to receive chemotherapy.
- Patients receiving anti-HER2 therapy for HER2 negative or HER2-positive primary treatment
Who cannot join
- When chemotherapy exceeded the first treatment
- Patients with multiple cancers
- Severe hypersensitivity reactions to anti-FGFR2 agents either now or in the past
- Patients with endocrine metabolic syndrome or history of calcium-phosphate homeostasis
- Patients with ectopic neoplasm or history of soft tissue, kidney, large intestine, heart, or abdomen
- Corneal lesions such as bullous keratopathy, corneal erosion, corneal erosion, corneal ulcer, corneal inflammation and keratoconjunctivitis were confirmed by ophthalmic examination
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- Patients with metastasis to the brain or meninges. However, patients who do not have symptoms and do not need treatment can register.
- Clinically significant digestive system problems that can cause abnormalities in taking or absorbing clinical drugs
- Patients with uncontrollable or significant cardiovascular disease
- Patients with systemic infections requiring treatment
- Patients who were exposed to paclitaxel at or before the taxane
- If you undergo major surgery within 28 days before enrollment for this trial
- Patients who received radiotherapy for gastric cancer within 28 days prior to enrollment for this trial. However, the investigation of bone turnover was conducted within 14 days before the registration for this trial
- If you received general chemotherapy within 14 days of enrollment for this trial
- Patients who are positive for human immunodeficiency virus (HIV-1) antibody test,
- HBsAg results positive, HBV viral load greater than 2000 IU / ml (104 copies / ml), or HCV antibody test positive
- Patients who are pregnant, lactating, or are likely to be pregnant
- Anemia and hair loss are excluded if previous chemotherapy treatment has toxicity that is not recovered below grade 2.
- Patients who are judged to have lost their ability to cope with dementia or other comorbid conditions
- Other Patients who the examiner or the examiner deemed inappropriate for the clinical trial.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Safety and Efficacy of INCB054828 in Combination With Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer With FGFs/FGFRs Genetic Aberration.
This study was conducted as a second-line treatment of recurrent / progressive gastric cancer patients with FGFs / FGFRs genetic mutations in the Ib / II clinical trial. The maximum maximal tolerated dose (MTD) and 2-phase recommended dose in combination with INCB054828 and paclitaxel (recommended phase II dose, RP2D), and evaluate the safety and clinical efficacy of this combination therapy. This study consists of two steps: Phase 1 is a dose escalation study to determine the maximum tolerated dose and 2-phase recommended dose of weekly paclitaxel and INCB054828 combination therapy, and Phase 2 is the dose escalation study in combination with INCB054828 and paclitaxel Assess safety and tolerability and identify antitumor effects in stomach cancer with FGFs / FGFRs genetic mutations.
Read the detailed description
- phase>
- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. 13.5mg, once a day begins to take. The paclitaxel is administered once a week for three consecutive weeks and then for one week, followed by a total of four weeks in one cycle.
- phase> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent. In its pre-screening phase, its next generation sequencing (NGS) is performed. Patients with FGFs / FGFRs genetic abnormalities may be enrolled in this study. If a patient has multiple genetic abnormalities, he or she will first be enrolled in a treatment group that targets a rare genetic abnormality. Registered patients will be treated on a continuous basis every four weeks.
- Being tested
- INCB054828, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB054828, PaclitaxelDrug
phase 1>
- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. phase 2> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 1. phase>
* INCB054828 begins with oral administration of 13.5 mg once a day.
* Paclitaxel is administered intravenously every week at 80mg / m2. (Days 1, 8 and 15) It is one cycle of 4 weeks and it is administered until the time of disease progression.
2. phase>
* INCB54828 is dosed at the dose specified in phase 1.
* Paclitaxel is administered intravenously every week at 80mg / m2. (Days 1, 8 and 15) It is one cycle of 4 weeks and it is administered until the time of disease progression Receives: Drug: INCB054828, Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Part 1, Phase Ib Maximum Tolerated dose (MTD)
Measured: 4 weeks
Recommended phase 2 dose (RP2D)
Part 1, Phase Ib Recommended phase 2 dose as determined by Dose limiting Toxicity (DLT).
Measured: 4 weeks
PFS
Prart 2, Phase II Progression-free survival (PFS): PFS is defined as the interval between the date of first dose and the earliest date of disease progression or death due to any cause.
Measured: 24 weeks
Secondary outcomes (4)
ORR
Objective Response Rate (ORR): The duration of response. ORR is defined as the percentage of subjects with a confirmed CR or PR per RECIST v1.1
Measured: 3 years
DCR
Disease Control Rate (DCR): DCR is the proportion of randomized patients achieving a best overall response of CR, PR, or SD.
Measured: 3 years
OS
Overall Survival (OS): OS is the time from the date of first dose and the date of death from any cause.
Measured: 3 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Safety and tolerability of the Varlitinib and Paclitaxel combination therapy as determined by: adverse events (categorized in accordance with CTCAE 4.03).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start27 May 2019
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, PaclitaxelStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SUN YOUNG RHA, Principal investigator, Yonsei Cancer Center, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529667
- Sponsor's protocol ID
- 4-2018-0327
- Status last verified
- May 2024
- First submitted
- 16 Aug 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Safety and Efficacy of INCB054828 in Combination With Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer With FGFs/FGFRs Genetic Aberration.
- ClinicalTrials.gov ID
- NCT05529667
- Acronym / sponsor ID
- 4-2018-0327
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 7 Sep 2022 (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 study was conducted as a second-line treatment of recurrent / progressive gastric cancer patients with FGFs / FGFRs genetic mutations in the Ib / II clinical trial. The maximum maximal tolerated dose (MTD) and 2-phase recommended dose in combination with INCB054828 and paclitaxel (recommended phase II dose, RP2D), and evaluate the safety and clinical efficacy of this combination therapy. This study consists of two steps: Phase 1 is a dose escalation study to determine the maximum tolerated dose and 2-phase recommended dose of weekly paclitaxel and INCB054828 combination therapy, and Phase 2 is the dose escalation study in combination with INCB054828 and paclitaxel Assess safety and tolerability and identify antitumor effects in stomach cancer with FGFs / FGFRs genetic mutations.
Detailed description
- phase>
- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. 13.5mg, once a day begins to take. The paclitaxel is administered once a week for three consecutive weeks and then for one week, followed by a total of four weeks in one cycle.
- phase> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent. In its pre-screening phase, its next generation sequencing (NGS) is performed. Patients with FGFs / FGFRs genetic abnormalities may be enrolled in this study. If a patient has multiple genetic abnormalities, he or she will first be enrolled in a treatment group that targets a rare genetic abnormality. Registered patients will be treated on a continuous basis every four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: INCB054828, Paclitaxel1. phase> * INCB054828 begins with oral administration of 13.5 mg once a day. * Paclitaxel is administered intravenously every week at 80mg / m2. (Days 1, 8 and 15) It is one cycle of 4 weeks and it is administered until the time of disease progression. 2. phase> * INCB54828 is dosed at the dose specified in phase 1. * Paclitaxel is administered intravenously every week at 80mg / m2. (Days 1, 8 and 15) It is one cycle of 4 weeks and it is administered until the time of disease progression |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who agreed in writing to the clinical study consent
- Histologically or cytologically confirmed advanced gastric adenocarcinoma. Patients must have experienced objective radiological or disease progress with evidence during or after primary therapy with fluoropyrimidine and platinum.
- FGFs / FGFRs have genetic variation on NGS.
- Patients whose life expectancy is at least 3 months
- If the Eastern Cooperative Oncology Group (ECOG) is 0 or 1
Key exclusion criteria (20 listed)
- When chemotherapy exceeded the first treatment
- Patients with multiple cancers
- Severe hypersensitivity reactions to anti-FGFR2 agents either now or in the past
- Patients with endocrine metabolic syndrome or history of calcium-phosphate homeostasis
- Patients with ectopic neoplasm or history of soft tissue, kidney, large intestine, heart, or abdomen
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 |
|---|---|---|
| INCB054828, Paclitaxelphase 1> - Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. phase 2> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent. | Drug | Experimental |
Primary outcome
MTD
Time frame: 4 weeks
Part 1, Phase Ib Maximum Tolerated dose (MTD)
Recommended phase 2 dose (RP2D)
Time frame: 4 weeks
Part 1, Phase Ib Recommended phase 2 dose as determined by Dose limiting Toxicity (DLT).
PFS
Time frame: 24 weeks
Prart 2, Phase II Progression-free survival (PFS): PFS is defined as the interval between the date of first dose and the earliest date of disease progression or death due to any cause.
4 secondary outcomes
ORR
Time frame: 3 years
DCR
Time frame: 3 years
OS
Time frame: 3 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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.
SUN YOUNG RHA principal investigator
Yonsei Cancer Center, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INCB054828, Paclitaxel in people with Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, Paclitaxel, run by Yonsei University at 1 site in South Korea.
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 9 inclusion and 20 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: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.