Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations (FGFR)
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| ClinicalTrials.gov Identifier: NCT05019794 |
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Recruitment Status :
Recruiting
First Posted : August 25, 2021
Last Update Posted : June 27, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Cancer Gastroesophageal Junction Adenocarcinoma Solid Tumor | Drug: Infigratinib | Phase 2 |
The subject will go through 4 periods, including Pre-screen period, screening period, treatment period and follow up period.
Pre-screening period (up to 28 days) For cohort 1, subject sign pre-screening ICF( Inform consent ), subject will do tumor biopsy or provide FFPE samples before prescreening for FGFR2-amp detection by FISH from the central laboratory. If the result is positive, subjects can go through the main screening stage, otherwise participants will be considered a prescreen failure. subjects can go through the main screening stage, otherwise participants will be considered a prescreen failure.
Screening period ( All cohorts; up to 28 days): Subjects who had positive genetic result could sign main ICF for all the screening examinations and establish study baseline documents. Only the eligible participants could enter the next treatment period.
Treatment period: Eligible subjects will be orally administered Infigratinib (125mg, QD) for 3 weeks on, 1-week off in each 28-day cycle until the occurrence of unacceptable toxicity, disease progression, withdrawing informed consent, death, contact lost, starting a new anticancer therapy, etc (whichever occurs first). During this period, subjects will be routinely assessed efficacy status by radiographic check at W9/W17/W25/W33 . After that, subjects will be evaluated every 12 weeks until disease progression. The safety assessment will be performed at cycle 1- 4;
Follow up period: Once a treatment discontinuation happens, subjects should return to the hospital within 30 days to receive a complete safety examination. Subjects with treatment discontinuation or disease progression should directly enter the follow-up period, visit approximately every 3 months for survival status reporting until withdrawing informed consent, death, contact lost, starting a new anti-cancer therapy, etc. (whichever occurs first).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase IIa of Infigratinib in Subjects With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma With FGFR2 Amplification or Other Advanced Solid Tumors With Other FGFR Alterations |
| Actual Study Start Date : | May 13, 2020 |
| Estimated Primary Completion Date : | December 30, 2022 |
| Estimated Study Completion Date : | December 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) with FGFR2 amplification
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off (every 4 weeks as one treatment cycle).
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Drug: Infigratinib
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Other Name: BGJ398 |
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Experimental: Advanced Solid tumors[Exclude GC/GEJ Arm and CHOL,UC]with FGFR1-3 fusions/rearrangements/mutations
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off (every 4 weeks as one treatment cycle).
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Drug: Infigratinib
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Other Name: BGJ398 |
- Objective Response Rate (ORR) [ Time Frame: Approximately 12 months after dosed ]Defined as the proportion of subjects with confirmed responses of CR or PR; Tumor response status will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Duration of response (DOR) [ Time Frame: Approximately 12 months after dosed ]Defined as from the first evaluation as CR or PR to the first evaluation as PD or death of any cause (percent of subjects with ≥6 months, ≥9 months, and ≥12 months DOR will be reported).
- Disease Control Rate (DCR) [ Time Frame: Approximately 12 months after dosed ]Defined as the proportion of subjects whose best overall response is confirmed to be CR or PR or SD (RECIST v1.1).
- Best Overall Response (BOR) [ Time Frame: Approximately 12 months after dosed ]Defined as best response recorded from the start of the study treatment until the disease progression/recurrence
- Progression-free survival (PFS) [ Time Frame: Approximately 12 months after dosed ]Defined as the time from the first date of treatment to the date of progression determined by investigator or death due to any cause.
- Overall Survival (OS) [ Time Frame: Approximately 24 months after dosed ]Defined as the time from the first date of treatment until date of death.
- Incidence of Adverse Events [ Time Frame: Approximately 24 months ]The incidence of adverse events is defined as the proportion of the patients, who have adverse event(s) since the time of main informed consent.
- Incidence of Serious Adverse Events [ Time Frame: Approximately 24 months ]The incidence of serious adverse events is defined as the proportion of the patients, who have serious adverse event(s) since the time of main informed consent.
- Incidence of Laboratory Abnormalities [ Time Frame: Approximately 24 months ]Incidence of abnormal laboratory is defined as the proportion of patients who have abnormal laboratory value since the time of main informed consent.
- Maximum plasma concentration (Cmax) [ Time Frame: Approximately 5 months. ]To characterize the pharmacokinetic parameter Maximum plasma concentration (Cmax) of Infigratinib following oral administration of Infigratinib in patients
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: Approximately 5 months. ]To characterize the pharmacokinetic parameter Area under the plasma concentration versus time curve (AUC) of Infigratinib following oral administration of Infigratinib in patients.
- Apparent total plasma clearance (CL/F) [ Time Frame: Approximately 5 months. ]To characterize the pharmacokinetic parameter Apparent total plasma clearance (CL/F) of Infigratinib following oral administration of Infigratinib in patients.
- Terminal elimination half-life (t1/2) [ Time Frame: Approximately 5 months. ]To characterize the pharmacokinetic parameter Terminal elimination half-life (t1/2) of Infigratinib following oral administration of Infigratinib in patients.
- Accumulation ratio (Racc) [ Time Frame: Approximately 5 months. ]To characterize the pharmacokinetic parameter Accumulation ratio (Racc) of Infigratinib following oral administration of Infigratinib in patients.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cohort 1 : 1) histologically or cytologically confirmed locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. 2) failed 2nd line or above therapy with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. 3) willing to do tumor biopsy for FGFR2 gene amplification via FISH test at central lab
- Cohort 2: 1) Histologically or cytologically confirmed locally advanced or metastatic solid tumors other than CHOL and UC. 2) Subjects must have failed established standard medical anti-cancer therapies for a diagnosed tumor or have been intolerant to such therapy, or no standard therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds.(3) Previous documented proof of FGFR1, FGFR2 ,or FGFR3 fusions/rearrangements and activating mutations (FISH/NGS/PCR results could be accepted) presented by local laboratory or central laboratory. [Except Cohort 1GC, or GEJ patients with FGFR2 amplification]
- Measurable disease by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria:
To be eligible for the study, subjects must not meet any of the following criteria:
- History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or nonmelanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study.
- Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
- Any known hypersensitivity to Infigratinib or its excipients.
- Subjects with symptomatic central nervous system metastasis.
- History and/or current evidence of extensive tissue calcification.
- Amylase or lipase >2.0 × ULN.
- Abnormal calcium or phosphorus, or calcium-phosphorus product ≥55 mg2/dL2.
- Current evidence of endocrine alterations of calcium/phosphate homeostasis.
- Current evidence of corneal or retinal disorder/keratopathy.
- Currently receiving or planning to receive treatment with agents or foods that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration during this study. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05019794
| Contact: Lei Mu, Master | 86 21 61329798 | Lei.mu@lianbio.com |
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| Study Director: | Qiao Sun, Doctor | Shanghai LianBio Development Co., Ltd. |
Publications:
| Responsible Party: | LianBio LLC |
| ClinicalTrials.gov Identifier: | NCT05019794 |
| Other Study ID Numbers: |
LB1001-201 |
| First Posted: | August 25, 2021 Key Record Dates |
| Last Update Posted: | June 27, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Gastric Cancer Receptors, Fibroblast Growth Factor Gastroesophageal Junction Solid tumor |
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Adenocarcinoma Stomach Neoplasms Esophageal Neoplasms Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Head and Neck Neoplasms Esophageal Diseases Infigratinib Antineoplastic Agents |