Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04096417|
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|FGFR1 Gene Amplification FGFR1 Gene Mutation FGFR1 Gene Translocation FGFR2 Gene Amplification FGFR2 Gene Mutation FGFR2 Gene Translocation FGFR3 Gene Amplification FGFR3 Gene Mutation FGFR3 Gene Translocation Metastatic Colorectal Carcinoma Stage III Colorectal Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Unresectable Colorectal Carcinoma||Drug: Pemigatinib Other: Quality-of-Life Assessment||Phase 2|
I. To assess overall response rate (ORR) of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring activating FGFR alterations.
I. To assess the clinical benefit rate (complete response + partial response + stable disease) with pemigatinib.
II. To assess progression free survival (PFS) and overall survival (OS) with pemigatinib.
III. Assess changes in patient quality of life (QOL) as measured by the linear analogue self-assessment (LASA) questionnaire.
IV. Assess the frequency and severity of adverse events.
CORRELATIVE RESEARCH OBJECTIVES:
I. To assess plasma pharmacodynamic biomarkers of response and resistance to therapy.
II. To explore any correlation between tissue and blood based biomarkers and clinical outcomes.
Patients receive pemigatinib orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years after registration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicenter, Single-Arm Study of Pemigatinib in Patients With Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2025|
Experimental: Treatment (pemigatinib)
Patients receive pemigatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Other Name: INCB054828
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Overall response rate (ORR) [ Time Frame: At 36 weeks after registration ]Defined as the percentage of patients, among evaluable patients, who experience an objective response per RECIST 1.1. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson.
- Clinical benefit rate [ Time Frame: Up to 36 weeks after registration ]Clinical Benefit Rate is defined as the number of patients that experience a complete or partial response within 36 weeks post registration, or have stable disease for at least 36 weeks post registration, divided by the number of evaluable patients. Analysis of this endpoint will mirror that of the primary objective.
- Progression-free survival (PFS) [ Time Frame: From study entry to the first of either disease progression or death from any cause, assessed up to 3 years after registration ]Progression-free survival (PFS) is defined as the time from study entry to the first of either disease progression or death from any cause, where disease progression is determined based on RECIST 1.1 criteria. PFS will be estimated using the Kaplan-Meier method. The median PFS and corresponding 95% confidence interval will be reported. Patients who do not experience disease progression or death while on protocol will be censored at the last disease assessment date.
- Overall survival (OS) [ Time Frame: From study entry to death from any cause, assessed up to 3 years after registration ]Overall survival (OS) is defined as the time from study entry to death from any cause. Will be estimated using the Kaplan-Meier method. The median OS and corresponding 95% confidence interval will be reported.
- Quality of Life (QOL) as measured by the LASA [item 1: Overall QOL] [ Time Frame: From baseline up to 36 weeks ]Quality of Life (QOL) was measured using item 1: Overall QOL of the Linear Analogue Self-Assessment (LASA) Questionnaire on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to Week 36 will be calculated by subtracting the baseline scores from the scores at Week 36. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.
- Incidence of adverse events [ Time Frame: Up to 3 years after registration ]Adverse events will be summarized by frequency and severity using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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): NCT04096417
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|Contact: Laurie A. Mihalik 480-342-6140 firstname.lastname@example.org|
|Principal Investigator: Tanios S. Bekaii-Saab|
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|Contact: Brenton Foretich 202-687-4346 email@example.com|
|Principal Investigator: Benjamin A. Weinberg|
|United States, Georgia|
|Emory University Hospital/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Contact: Kim Nguyen 404-778-5680 firstname.lastname@example.org|
|Principal Investigator: Bassel F. El-Rayes|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Contact: Heather Macauley 773-702-9251 email@example.com|
|Principal Investigator: Daniel V. Catenacci|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Contact: Jesse A. Huffman 314-747-6268 firstname.lastname@example.org|
|Principal Investigator: Katrina S. Pedersen|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Contact: Francisco J. Cordero 919-681-3095 email@example.com|
|Principal Investigator: John H. Strickler|
|United States, Tennessee|
|Vanderbilt University/Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Contact: Jennifer G. Whisenant 615-875-8630 firstname.lastname@example.org|
|Principal Investigator: Kristen K. Ciombor|
|United States, Wisconsin|
|Aurora Cancer Care-Milwaukee West|
|Wauwatosa, Wisconsin, United States, 53226|
|Contact: Jennifer Mathieu 414-302-2312 email@example.com|
|Principal Investigator: Federico Augusto H. Sanchez|
|Principal Investigator:||Kristen K Ciombor||Academic and Community Cancer Research United|