Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
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|ClinicalTrials.gov Identifier: NCT04233567|
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm Cholangiocarcinoma Metastatic Malignant Solid Neoplasm Refractory Malignant Solid Neoplasm||Drug: Infigratinib||Phase 2|
I. To evaluate the efficacy of single agent infigratinib in patients with advanced or metastatic solid tumors of any histologic classification with FGFR1-3 gene fusions/translocations or other FGFR genetic alterations (with and without prior therapy with different FGFR inhibitor).
II. To understand response rate and potential for infigratinib to benefit patients who have FGFR alterations including point mutations, insertions/deletions and amplifications in different solid tumor types.
I. To further evaluate the efficacy of single agent infigratinib. II. To characterize the safety and tolerability of single agent infigratinib. II. To evaluate benefit of infigratinib in patients who have received one prior FGFR inhibitor.
I. To detect biomarkers of resistance to infigratinib treatment through tumor sequencing.
II. To develop a circulating tumor deoxyribonucleic acid (DNA) (ctDNA) or liquid biopsy assay optimized for monitoring response to infigratinib and detecting emerging resistance mutations to infigratinib.
Patients receive infigratinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients who complete study treatment for any reason other than disease progression are followed for 30 days, every 8 weeks until disease progression, and then every 4 months for 1 year. All other patients are followed for 30 days, and then every 4 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oral Infigratinib in Adult Patients With Advanced or Metastatic Solid Tumors With FGFR1-3 Gene Fusions or Other FGFR Genetic Alterations|
|Actual Study Start Date :||January 16, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Treatment (infigratinib)
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Overall response rate (ORR) [ Time Frame: 6 cycles of treatment or upon treatment discontinuation ]Assessed by investigator as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. The estimated ORR will be presented along with the corresponding 90% confidence interval for each cohort, based on a binomial distribution.
- Progression free survival (PFS) [ Time Frame: From start of treatment to the date of the event defined as the first documented progression or death due to any cause, assessed up to 1 year post-treatment ]Assessed by investigator as per RECIST v1.1. Kaplan-Meier analysis of PFS will be conducted for each cohort.
- Best overall response (BOR) [ Time Frame: Up to 1 year post-treatment ]Assessed by investigator as per RECIST v1.1. BOR will be summarized for the cohorts using the ORR and the disease control rate which are the proportion of patients having respectively a best overall response of partial response (PR) or complete response (CR), or stable disease (SD), PR or CR. The estimated ORR and corresponding 90% confidence intervals based on the binomial distribution will be reported.
- Disease control rate [ Time Frame: Up to 1 year post-treatment ]Assessed by investigator as per RECIST v1.1.
- Overall survival (OS) [ Time Frame: From the date of start of treatment to the date of death due to any cause, will be assessed at 4, 6, 8,12 and 24 months ]Assessed by investigator as per RECIST v1.1. Will be analyzed using the Kaplan Meier method. Survival rate at 4, 6, 8, 12, 18 and 24 months and median OS will be estimated along with 95% confidence intervals from the Kaplan Meier distribution.
- Incidence of adverse events (AEs) [ Time Frame: Up to 30 days post-treatment ]Will be tabulated and presented. All AEs occurring during the study will be included in by-patient data listings and tabulated by organ class and preferred term. Adverse events will be summarized overall, by relationship and by severity. Events leading to death, serious (S)AE, and events resulting in treatment discontinuation will be tabulated. Individual patient laboratory parameter values and summary statistics over time will be prepared using descriptive statistics. Severity of select clinical laboratory measures will be determined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5 criteria and grade 3 or 4 laboratory values will be presented in a separate patient listing.
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): NCT04233567
|Contact: The Ohio State University Comprehensive Cancer Center||1-800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Shona Taylorfirstname.lastname@example.org|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Sameek Roychowdhury, MD 614-685-5841 Sameek.Roychowdhury@osumc.edu|
|Principal Investigator: Sameek Roychowdhury, MD|
|Principal Investigator:||Sameek Roychowdhury, M.D.||Ohio State University Comprehensive Cancer Center|