Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
NCT ID: NCT04096417
Last Updated: 2024-02-21
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
14 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-08-31
Study Completion Date
2025-12-01
Brief Summary
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This phase II trial studies how well pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.
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Detailed Description
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PRIMARY OBJECTIVE:
I. To assess overall response rate (ORR) of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring activating FGFR alterations.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
I. To assess overall response rate (ORR) of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring activating FGFR alterations.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
Conditions
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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
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Pemigatinib
Intervention Type
DRUG
Given PO
Quality-of-Life Assessment
Intervention Type
OTHER
Ancillary studies
Interventions
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Pemigatinib
Given PO
Intervention Type
DRUG
Quality-of-Life Assessment
Ancillary studies
Intervention Type
OTHER
Other Intervention Names
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INCB054828
Quality of Life Assessment
Eligibility Criteria
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Inclusion Criteria
* Registered to Colorectal and Liquid Biopsy Molecularly Assigned Therapy (COLOMATE) Academic and Community Cancer Research United (ACCRU)-GI-1611 and:
* COLOMATE Companion Trial Recommendation Form indicates patient qualifies to be screened for a COLOMATE companion trial
* COLOMATE Companion Trial Recommendation Form date of completion is =\< 30 days prior to registration
* Histologically or cytologically confirmed diagnosis of metastatic or unresectable colorectal cancer (mCRC), based on documentation from local or outside review of pathology according to each site?s established institutional procedure
* Documentation of an activating genomic alteration(s) in FGFR1-3 (gain of function mutations, translocations, and amplifications allowed)
* Provide informed written consent
* Patient must have received and progressed on, or be intolerant to, each of the following treatments for mCRC (or have contraindication to these treatments):
* Fluoropyrimidine
* Oxaliplatin
* Irinotecan
* Anti-VEGF (vascular endothelial growth factor) monoclonal antibody, if eligible for this therapy
* Anti-EGFR (epidermal growth factor receptor) monoclonal antibody, if eligible for this therapy
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration)
* Platelet count \>= 100,000/mm\^3 (obtained =\< 28 days prior to registration)
* Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to registration)
* Total bilirubin =\< 1.5x upper limit of normal (ULN), or =\< 2.5x ULN if patient has Gilbert syndrome or disease involving the liver (obtained =\< 28 days prior to registration)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5x ULN (or =\< 5x ULN in presence of suspected liver metastases) (obtained =\< 28 days prior to registration)
* Serum phosphate \< institutional ULN (obtained =\< 28 days prior to registration)
* Serum calcium within institutional normal range, or serum albumin-corrected calcium within institutional normal range (if serum albumin is outside of the institutional normal range) (obtained =\< 28 days prior to registration)
* Potassium levels \> institutional lower limit of normal (supplementation can be used to correct potassium level during screening) (obtained =\< 28 days prior to registration)
* Serum creatinine =\< 1.5x ULN, or calculated creatinine clearance \> 30 mL/min using the Cockcroft-Gault formula or 24-hours urine collection analysis (obtained =\< 28 days prior to registration)
* Corrected QT interval (QTc) by Fridericia?s method (QTcF) assessed by electrocardiogram (ECG) completed =\< 28 days prior to registration, and resulted as:
* QTcF =\< 450 msec in men, or
* QTcF =\< 470 msec in women
* Negative serum pregnancy test completed =\< 7 days prior to registration, for women of childbearing potential only
* Willing to provide tissue and blood samples for correlative research purposes
* Willing to allow transfer of tissue and blood samples, clinical information, and outcome data collected from this trial for future research
* COLOMATE Companion Trial Recommendation Form indicates patient qualifies to be screened for a COLOMATE companion trial
* COLOMATE Companion Trial Recommendation Form date of completion is =\< 30 days prior to registration
* Histologically or cytologically confirmed diagnosis of metastatic or unresectable colorectal cancer (mCRC), based on documentation from local or outside review of pathology according to each site?s established institutional procedure
* Documentation of an activating genomic alteration(s) in FGFR1-3 (gain of function mutations, translocations, and amplifications allowed)
* Provide informed written consent
* Patient must have received and progressed on, or be intolerant to, each of the following treatments for mCRC (or have contraindication to these treatments):
* Fluoropyrimidine
* Oxaliplatin
* Irinotecan
* Anti-VEGF (vascular endothelial growth factor) monoclonal antibody, if eligible for this therapy
* Anti-EGFR (epidermal growth factor receptor) monoclonal antibody, if eligible for this therapy
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration)
* Platelet count \>= 100,000/mm\^3 (obtained =\< 28 days prior to registration)
* Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to registration)
* Total bilirubin =\< 1.5x upper limit of normal (ULN), or =\< 2.5x ULN if patient has Gilbert syndrome or disease involving the liver (obtained =\< 28 days prior to registration)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5x ULN (or =\< 5x ULN in presence of suspected liver metastases) (obtained =\< 28 days prior to registration)
* Serum phosphate \< institutional ULN (obtained =\< 28 days prior to registration)
* Serum calcium within institutional normal range, or serum albumin-corrected calcium within institutional normal range (if serum albumin is outside of the institutional normal range) (obtained =\< 28 days prior to registration)
* Potassium levels \> institutional lower limit of normal (supplementation can be used to correct potassium level during screening) (obtained =\< 28 days prior to registration)
* Serum creatinine =\< 1.5x ULN, or calculated creatinine clearance \> 30 mL/min using the Cockcroft-Gault formula or 24-hours urine collection analysis (obtained =\< 28 days prior to registration)
* Corrected QT interval (QTc) by Fridericia?s method (QTcF) assessed by electrocardiogram (ECG) completed =\< 28 days prior to registration, and resulted as:
* QTcF =\< 450 msec in men, or
* QTcF =\< 470 msec in women
* Negative serum pregnancy test completed =\< 7 days prior to registration, for women of childbearing potential only
* Willing to provide tissue and blood samples for correlative research purposes
* Willing to allow transfer of tissue and blood samples, clinical information, and outcome data collected from this trial for future research
Exclusion Criteria
* Prior treatment with pemigatinib
* Prior treatment with a selective FGFR inhibitor =\< 180 days (6 months) prior to registration
* Known hypersensitivity or severe reaction to an FGFR inhibitor, or to the excipients of pemigatinib (i.e. microcrystalline cellulose, sodium starch glycolate, and magnesium stearate)
* Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination
* Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications =\< 14 days prior to registration
* Major surgery =\< 28 days prior to registration
* External beam radiation therapy =\< 28 days prior to registration, or palliative radiation for non-central nervous system (CNS) disease =\< 14 days prior to registration
* Brain metastases, central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
* NOTE: Patients who are asymptomatic or previously treated and stable, without evidence of progression for \>= 28 days prior to registration are eligible
* NOTE: Patients taking concomitant corticosteroids and/or anticonvulsants are allowed if patient is on a stable or decreasing dose of such treatment for \>= 28 days prior to registration
* History or presence of significant cardiovascular disease or condition including:
* Uncontrolled angina pectoris (Canadian Cardiovascular Society grade II-IV despite medical therapy)
* Congestive heart failure (New York Heart Association class III or IV)
* Uncontrolled arrhythmia requiring therapy. Note: Patients with a pacemaker and well-controlled rhythm for \>= 28 days prior to registration are not excluded
* Any of the following occurring =\< 6 months prior to registration: myocardial infarction, angioplasty, cardiac stenting, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack
* Failure to adequately recover (i.e. to =\< grade 1 \[according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5\] or to pre-treatment baseline) from adverse events (AEs) deemed by the investigator as clinically significant and attributed to prior therapy. Exception: alopecia
* Current use of prohibited medication
* Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers =\< 14 days or 5 half-lives (whichever is shorter) prior to registration. Note: topical ketoconazole will be allowed
* History of hypovitaminosis D requiring supraphysiologic doses to replenish the deficiency. Note: patients receiving vitamin D food supplements are allowed
* History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung; with the exception of calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification
* Unable or unwilling to swallow pemigatinib and keep a medication diary, or significant gastrointestinal disorder(s) that could interfere with absorption, metabolism or excretion of pemigatinib per the discretion of the investigator
* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
* Pregnant women
* Nursing women
* Women of childbearing potential or men able to father children who have a female partner of childbearing potential, who are unwilling to employ acceptable contraception
* Known history of human immunodeficiency (HIV) infection or positivity on immunoassay confirmed per local standards
* Note: HIV test is not required for screening, but patients with a known history of HIV infection will be excluded
* Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Other known active malignancy =\< 5 years prior to registration
* EXCEPTIONS: Non-melanotic skin cancer or carcinoma in situ of the cervix, provided there is no known active disease and no additional therapy for the condition is ongoing or required during the trial period
* NOTE: anti-estrogen/androgen therapy or bisphosphonates allowed
* Co-morbid systemic illness, other severe concurrent disease, or psychiatric illness/social situation which, in the judgment of the investigator, would make the patient inappropriate for entry into this study, limit compliance with study requirements, or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimen
* Prior treatment with a selective FGFR inhibitor =\< 180 days (6 months) prior to registration
* Known hypersensitivity or severe reaction to an FGFR inhibitor, or to the excipients of pemigatinib (i.e. microcrystalline cellulose, sodium starch glycolate, and magnesium stearate)
* Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination
* Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications =\< 14 days prior to registration
* Major surgery =\< 28 days prior to registration
* External beam radiation therapy =\< 28 days prior to registration, or palliative radiation for non-central nervous system (CNS) disease =\< 14 days prior to registration
* Brain metastases, central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
* NOTE: Patients who are asymptomatic or previously treated and stable, without evidence of progression for \>= 28 days prior to registration are eligible
* NOTE: Patients taking concomitant corticosteroids and/or anticonvulsants are allowed if patient is on a stable or decreasing dose of such treatment for \>= 28 days prior to registration
* History or presence of significant cardiovascular disease or condition including:
* Uncontrolled angina pectoris (Canadian Cardiovascular Society grade II-IV despite medical therapy)
* Congestive heart failure (New York Heart Association class III or IV)
* Uncontrolled arrhythmia requiring therapy. Note: Patients with a pacemaker and well-controlled rhythm for \>= 28 days prior to registration are not excluded
* Any of the following occurring =\< 6 months prior to registration: myocardial infarction, angioplasty, cardiac stenting, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack
* Failure to adequately recover (i.e. to =\< grade 1 \[according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5\] or to pre-treatment baseline) from adverse events (AEs) deemed by the investigator as clinically significant and attributed to prior therapy. Exception: alopecia
* Current use of prohibited medication
* Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers =\< 14 days or 5 half-lives (whichever is shorter) prior to registration. Note: topical ketoconazole will be allowed
* History of hypovitaminosis D requiring supraphysiologic doses to replenish the deficiency. Note: patients receiving vitamin D food supplements are allowed
* History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung; with the exception of calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification
* Unable or unwilling to swallow pemigatinib and keep a medication diary, or significant gastrointestinal disorder(s) that could interfere with absorption, metabolism or excretion of pemigatinib per the discretion of the investigator
* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
* Pregnant women
* Nursing women
* Women of childbearing potential or men able to father children who have a female partner of childbearing potential, who are unwilling to employ acceptable contraception
* Known history of human immunodeficiency (HIV) infection or positivity on immunoassay confirmed per local standards
* Note: HIV test is not required for screening, but patients with a known history of HIV infection will be excluded
* Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Other known active malignancy =\< 5 years prior to registration
* EXCEPTIONS: Non-melanotic skin cancer or carcinoma in situ of the cervix, provided there is no known active disease and no additional therapy for the condition is ongoing or required during the trial period
* NOTE: anti-estrogen/androgen therapy or bisphosphonates allowed
* Co-morbid systemic illness, other severe concurrent disease, or psychiatric illness/social situation which, in the judgment of the investigator, would make the patient inappropriate for entry into this study, limit compliance with study requirements, or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimen
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Academic and Community Cancer Research United
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Kristen K Ciombor
Role: PRINCIPAL_INVESTIGATOR
Academic and Community Cancer Research United
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Site Status
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Site Status
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Site Status
Duke University Medical Center
Durham, North Carolina, United States
Site Status
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Site Status
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Site Status
Countries
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United States
References
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Wheless MC, Zemla TJ, Hubbard JM, Strickler JH, Gbolahan OB, Wilson L, Waechter B, Ou FS, Nixon AB, Bekaii-Saab TS, Ciombor KK. A phase II, multicenter, single-arm study of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring FGFR alterations. Oncologist. 2025 Jun 4;30(6):oyaf069. doi: 10.1093/oncolo/oyaf069.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2019-05877
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACCRU-GI-1701
Identifier Type: OTHER
Identifier Source: secondary_id
ACCRU-GI-1701
Identifier Type: -
Identifier Source: org_study_id
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