Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations

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Brief Title

Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations

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

Brief Summary

      This phase II trial studies how well infigratinib works in treating solid tumors that have
      spread to other places in the body (advanced or metastatic) in patients with FGFR gene
      mutations such as FGFR1-3 gene fusions or other FGFR genetic alterations. Mutations are any
      changes in the genetic material (DNA) of a cell. FGFR proteins are involved in cell division,
      cell maturation, formation of new blood vessels, wound healing, and bone growth, development,
      and maintenance. FGFR mutations can cause the FGFR protein to become over-active in diseases
      such as cancer. Infigratinib may stop the growth of tumor cells by blocking FGFR proteins in
      these tumors.
    

Detailed Description

      PRIMARY OBJECTIVES:

      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.

      SECONDARY OBJECTIVES:

      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.

      EXPLORATORY OBJECTIVES:

      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.

      OUTLINE:

      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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall response rate (ORR)

Secondary Outcome

 Progression free survival (PFS)

Condition

Advanced Malignant Solid Neoplasm

Intervention

Infigratinib

Study Arms / Comparison Groups

 Treatment (infigratinib)
Description:  Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

January 16, 2020

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed advanced or metastatic solid
             tumors of any histologic classification at the time of diagnosis

          -  Written documentation of local or central Clinical Laboratory Improvement Act
             (CLIA)-certified laboratory determination of FGFR gene fusions/translocations or
             activating mutations

          -  The study is open to solid tumors in the following cohorts:

               -  Cohort 1: Solid tumor patients with FGFR1-3 fusion/translocation (n=10) who have
                  progressed on or are intolerant to standard of care (SOC) therapies and received
                  treatment with a different FGFR inhibitor. Cholangiocarcinoma patients are
                  permitted in this cohort

               -  Cohort 2: Solid tumor patients with FGFR1-3 fusion/translocation (n, up to 30)
                  who have progressed on or are intolerant to SOC therapies. Prior therapy with a
                  different FGFR inhibitor is not permitted. Cholangiocarcinoma patients are
                  excluded from this cohort (there are multiple competing studies and opportunities
                  for patients to get treatment in other trials)

               -  Cohort 3: Solid tumor patients with genetic alterations such as point mutations,
                  insertions/deletions, or amplifications in any FGFR gene family member (n=10).
                  Prior therapy with a different FGFR inhibitor is not permitted.
                  Cholangiocarcinoma patients are permitted in this cohort

          -  Evidence of measurable or evaluable disease according to Response Evaluation Criteria
             in Solid Tumors (RECIST) version 1.1

          -  Patients must have received at least one prior SOC regimen for advanced/metastatic
             cancer. Patient should have had evidence of progressive disease following their prior
             regimen, or if prior treatment was discontinued due to toxicity must have continued
             evidence of measurable or evaluable disease. Patients who have received prior
             treatment with an alternate FGFR inhibitor are still eligible for the study

          -  Patients with primary central nervous system (CNS) cancer or CNS metastases are
             excluded (because it is unclear how much CNS penetration the drug has). However,
             asymptomatic patients with history of successfully treated CNS metastases with surgery
             or radiation and follow up imaging showing stability, can be eligible

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (patients with ECOG
             performance status of 2 may be considered on a case-by-case basis after discussion
             with QED Therapeutics)

          -  Able to read and/or understand the details of the study and provide written evidence
             of informed consent as approved by Institutional Review Board (IRB)/Ethics Committee
             (EC)

          -  Recovery from adverse events of previous systemic anti-cancer therapies to baseline or
             grade 1, except for:

               -  Alopecia

               -  Stable neuropathy of =< grade 2 due to prior cancer therapy

          -  Able to swallow and retain oral medication

          -  Willing and able to comply with scheduled visits, treatment plan and laboratory tests

        Exclusion Criteria:

          -  Patients who have therapies available that are known to confer a clinical benefit will
             be excluded from the study

          -  Neurological symptoms related to underlying disease requiring increasing doses of
             corticosteroids. Note: Steroid use for management of CNS tumors is allowed but must be
             at a stable dose for at least 2 weeks preceding study entry

          -  History of another primary malignancy except adequately treated in situ carcinoma of
             the cervix or non-melanoma 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 or affect survival

          -  Any other medical condition that would, in the investigator's judgment, prevent the
             patient's participation in the clinical study due to safety concerns or compliance
             with clinical study procedures

          -  Current evidence of corneal or retinal disorder/keratopathy including, but not limited
             to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration,
             keratoconjunctivitis, confirmed by ophthalmologic examination

          -  History and/or current evidence of extensive tissue calcification including, but not
             limited to, the soft tissue, kidneys, intestine, myocardium and lung with the
             exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and
             asymptomatic coronary calcification

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of oral infigratinib (e.g., ulcerative diseases, uncontrolled
             nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)

          -  Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g.,
             parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis
             etc

          -  Treatment with any of the following anti-cancer therapies prior to the first dose of
             infigratinib within the stated timeframes:

               -  Cyclical chemotherapy (intravenous) within a period of time that is shorter than
                  the cycle length used for that treatment (e.g., 6 weeks for nitrosourea,
                  mitomycin-C)

               -  Biological therapy (e.g., antibodies - including bevacizumab) within a period of
                  time that is =< 5 half-life (t1/2) or =< 4 weeks, whichever is shorter, prior to
                  starting study drug

               -  Continuous or intermittent small molecule therapeutics within a period of time
                  that is =< 5 t1/2 or =< 4 weeks (whichever is shorter) prior to starting study
                  drug

               -  Any other investigational agents within a period of time that is =< 5 t1/2 or
                  less than the cycle length used for that treatment or =< 4 weeks (whichever is
                  shortest) prior to starting study drug

               -  Wide field radiotherapy (including therapeutic radioisotopes such as strontium
                  89) =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to
                  starting study drug

          -  Patients who are currently receiving treatment with agents that are known strong
             inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus
             and/or calcium concentration are excluded. Patients are not permitted to receive
             enzyme-inducing anti-epileptic drugs

          -  Consumption of grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star
             fruits, pomelos, Seville oranges or products within 7 days prior to first dose

          -  Use of medications that are known to prolong the QT interval and/or are associated
             with a risk of Torsades de Pointes (TdP) 7 days prior to first dose

          -  Use of amiodarone within 90 days prior to first dose

          -  Current use of therapeutic doses of warfarin sodium or any other coumadin-derivative
             anticoagulants. Heparin and/or low molecular weight heparins are allowed

          -  Absolute neutrophil count (ANC) =< 1,000/mm^3 (1.0 x 10^9/L)

          -  Platelets =< 75,000/mm^3 (75 x 10^9/L)

          -  Hemoglobin =< 9.0 g/dL

          -  Total bilirubin >= 1.5 x upper limit of normal (ULN) unless associated with patient's
             primary cancer and/or metastases and with principal investigator's approval

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >= 3 x ULN unless
             associated with patient's primary cancer and/or metastases and with principal
             investigator's approval

          -  Alkaline phosphatase >= 2.5 x ULN unless associated with patient's primary cancer
             and/or metastases and with principal investigator's approval

          -  Calculated or measured creatinine clearance of < 40 mL/min

          -  Calcium-phosphate homeostasis:

               -  Inorganic phosphorus outside of institutional normal limits

               -  Total serum calcium (can be corrected) outside of institutional normal limits

          -  Clinically significant cardiac disease including any of the following:

               -  Congestive heart failure requiring treatment (New York Heart Association [NYHA]
                  grade >= 2), left ventricular ejection fraction (LVEF) < 50% as determined by
                  multi-gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled
                  hypertension (refer to World Health Organization [WHO] and International Society
                  for Hypertension [ISH] guidelines)

               -  History or presence of clinically significant ventricular arrhythmias, atrial
                  fibrillation, resting bradycardia, or conduction abnormality

               -  Unstable angina pectoris or acute myocardial infarction =< 3 months prior to
                  starting study drug

               -  Corrected QT using Fridericia's formula (QTcF) > 470 msec (males and females)

               -  History of congenital long QT syndrome

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadotropin (hCG) laboratory test

          -  Women of child-bearing potential (WOCBP), defined as all women physiologically capable
             of becoming pregnant, unless they are using highly effective methods of contraception
             during dosing and for 3 months following the discontinuation of study treatment.
             Highly effective contraception methods include:

               -  Total abstinence (when this is in line with the preferred and usual lifestyle of
                  the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal,
                  post-ovulation methods) and withdrawal are not acceptable methods of
                  contraception

               -  Female sterilization (have had surgical bilateral oophorectomy with or without
                  hysterectomy) or tubal ligation at least six weeks before taking study treatment.
                  In case of oophorectomy alone, only when the reproductive status of the woman has
                  been confirmed by follow-up hormone level assessment

               -  Male sterilization (at least 6 months prior to screening). For female patients on
                  the study the vasectomized male partner should be the sole partner for that
                  patient

               -  Use of oral, injected or implanted hormonal methods of contraception or placement
                  of an intrauterine device (IUD) or intrauterine systems (IUS), or other forms of
                  hormonal contraception that have comparable efficacy (failure rate < 1%), for
                  example hormone vaginal ring or transdermal hormone contraception

               -  In case of use of oral contraception women should have been stable on the same
                  pill for a minimum of 3 months before taking study treatment. Women are
                  considered post-menopausal and not of child bearing potential if they have had 12
                  months of natural (spontaneous) amenorrhea with an appropriate clinical profile
                  (e.g. age appropriate, history of vasomotor symptoms) or have had surgical
                  bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least
                  6 weeks ago. In the case of oophorectomy alone, only when the reproductive status
                  of the woman has been confirmed by follow-up hormone level assessment is she
                  considered not of child bearing potential

          -  Sexually active males unless they use a condom during intercourse while taking drug
             and for 3 months after the last dose of the study drug and should not father a child
             in this period. A condom is required to be used also by vasectomized men as well as
             during intercourse with a male partner in order to prevent delivery of the drug via
             seminal fluid
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sameek Roychowdhury, M.D., 1-800-293-5066, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04233567

Organization ID

OSU-19041

Secondary IDs

NCI-2019-06869

Responsible Party

Sponsor-Investigator

Study Sponsor

Sameek Roychowdhury

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Sameek Roychowdhury, M.D., Principal Investigator, Ohio State University Comprehensive Cancer Center


Verification Date

February 2020