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Brief Title

Phase I BLASST-3 Trial

Official Title

Biomarker-directed Neoadjuvant Therapy for Cisplatin-ineligible or Cisplatin-refusing Muscle-invasive Bladder Cancer: Phase I Bladder Cancer Signal Seeking Trial

Brief Summary

      The aim of this research is to see whether using a drug that blocks a protein called FGFR
      (fibroblast growth factor receptor) prior to surgery is safe and effective in patients with
      bladder cancer that have mutations in FGFR3 or FGFR2 and who cannot receive chemotherapy with
      cisplatin prior to surgery

      The name of the study drug involved in this study is:

      - Infigratinib
    

Detailed Description

      This is a single-center (DF/HCC) prospective feasibility study to assess biomarker-directed
      neoadjuvant therapy in patients with cT2-T4aN0 MIBC who are candidates for radical cystectomy
      (RC) and ineligible for, or refuse, cisplatin-based neoadjuvant chemotherapy (NAC).

      This research study involves using a drug that inhibits FGFR in patients with bladder cancer
      (that have mutations in FGFR) prior to surgery.

      The name of the study drug involved in this study is:

      - Infigratinib

      The research study procedures include pre-screening for eligibility and study treatment
      including evaluations and follow up visits. This pre-screening is already done as clinical
      care. Study participants will receive study treatment for 2 months prior to surgery and will
      be followed for at least 1 year after undergoing surgery.

      It is expected that about 12 people will take part in this research study.

      This research study is a Phase I clinical trial, which tests the safety of an investigational
      drug (infigratinib) and also tries to define the appropriate dose of the investigational drug
      to use for further studies. "Investigational" means that the drug is being studied.

      This research study is also a Feasibility Study, which is the first time investigators are
      examining this drug in patients with bladder cancer that has not spread to other organs. The
      U.S. Food and Drug Administration (FDA) has not approved infigratinib as a treatment for any
      disease.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

≥ 70% of patients receiving at least 1 dose of study treatment followed by completion of radical cystectomy (Feasibility)

Secondary Outcome

 Pathologic response (					

Condition

Bladder Transitional Cell Carcinoma

Intervention

Infigratinib

Study Arms / Comparison Groups

 Infigratinib
Description:  Infigratinib daily dosage per protocol 3-week on/1-week off schedule. 4 weeks will constitute 1 cycle of therapy.
Participants will receive 2 cycles (i.e. 8 weeks) and the treatment will be administered as an outpatient.
After completion of therapy, patients will undergo a CT of the chest, abdomen and pelvis (within 2 weeks of the last dose of therapy) and then proceed to Radical cystectomy 2-4 weeks after the last dose of therapy.

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

12

Start Date

December 2021

Completion Date

January 25, 2023

Primary Completion Date

July 25, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Written informed consent and any locally-required authorization (e.g. HIPAA) obtained
             from the patient prior to performing any protocol-related procedures, including
             screening evaluations

          -  Age ≥ 18 years at time of study entry (no safety data in pediatric patients is
             available for infigratinib).

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (See Appendix
             A).

          -  Histologically confirmed bladder transitional cell carcinoma (TCC)

             -- Patients with mixed histology are required to have a component of TCC, and no
             component of small cell histology

          -  cT2-T4a N0 M0 disease after radiographic staging of chest, abdomen and pelvis,
             considered appropriate and planned for radical cystectomy as assessed by a Urologic
             Oncologist.

          -  Presence of the following FGFR3/2 activating alterations, as detected by either plasma
             or urine cfDNA or cfRNA or by tissue-based NGS (Predicine, Hayward, CA):

               -  Mutations in exon 7 (R248C, S249C)

               -  Mutations in exon 10 (G372C, A393E, Y375C)

               -  Mutations in exon 15 (K652M/T, K652E/Q)

               -  Any FGFR3/2 gene fusion (Availability of baseline archival tumor tissue for
                  identification of FGFR3/2 alterations is not required, but tissue will be
                  obtained when available including either FFPE tumor tissue block or a minimum of
                  fifteen 5μm unstained FFPE slides and fifteen 10μm unstained FFPE slides with an
                  associated pathology report is required)

          -  Ineligibility for cisplatin-based chemotherapy, defined by any of the following:

               -  Creatinine clearance (CL) <60 mL/min. GFR should be calculated from serum/plasma
                  creatinine using the Cockcroft-Gault formula.

               -  CTCAE v5.0 Grade > 1 hearing loss

               -  CTCAE v5.0 Grade > 1 neuropathy

               -  NYHA Class > II cardiac dysfunction

               -  Patients not meeting the above criteria are eligible if he/she declines
                  neoadjuvant cisplatin-based chemotherapy after specific informed consent
                  describing the known benefits of cisplatin-based chemotherapy. The reason for
                  cisplatin-ineligibility based on the above criteria or cisplatin refusal should
                  be documented on the case report form.

          -  Adequate organ function laboratory values as defined below:

               -  Hemoglobin ≥ 9.0 g/dL

               -  Absolute neutrophil count (ANC) 1.5 x (> 1500 per mm3)

               -  Platelet count ≥100 x 109/L (>75,000 per mm3)

               -  International Normalized Ratio (INR) or activated partial thromboplastin time
                  (aPTT) < 1.5 x ULN, unless the patient is receiving anticoagulation therapy
                  provided INR or PTT is within the therapeutic range of the intended anticoagulant
                  therapy.

          -  Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)

             -- This will not apply to patients with confirmed Gilbert's syndrome (persistent or
             recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of
             hemolysis or hepatic pathology), who will be allowed only in consultation with their
             physician.

          -  AST (SGOT)/ALT (SGPT) ≤1.5 x institutional upper limit of normal

          -  Measured creatinine CL >30 mL/min or Calculated creatinine CL>30 mL/min by the
             Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine
             clearance:

               -  Males: Creatinine CL (mL/min) = Weight (kg) x (140 - Age)/72 x serum creatinine
                  (mg/dL)

               -  Females: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85/ 72 x serum
                  creatinine (mg/dL)

          -  Evidence of post-menopausal status or negative urinary or serum pregnancy test for
             female pre-menopausal patients. Women will be considered post-menopausal if they have
             been amenorrheic for 12 months without an alternative medical cause. The following
             agespecific requirements apply:

               -  Women <50 years of age would be considered post-menopausal if they have been
                  amenorrheic for 12 months or more following cessation of exogenous hormonal
                  treatments and if they have luteinizing hormone and follicle-stimulating hormone
                  levels in the post-menopausal range for the institution or underwent surgical
                  sterilization (bilateral oophorectomy or hysterectomy).

               -  Women ≥50 years of age would be considered post-menopausal if they have been
                  amenorrheic for 12 months or more following cessation of all exogenous hormonal
                  treatments, had radiation-induced menopause with last menses >1 year ago, had
                  chemotherapy-induced menopause with last menses >1 year ago, or underwent
                  surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or
                  hysterectomy).

          -  Patient has ability and willingness to sign a written informed consent document and is
             willing and able to comply with the protocol for the duration of the study including
             undergoing treatment and scheduled visits and examinations including follow up.

        Exclusion Criteria:

          -  Patients with primary TCC of the ureter, urethra, or renal pelvis without TCC of the
             bladder

          -  Inoperable tumor(s) with fixation to the pelvic wall on clinical exam

          -  Any previous systemic chemotherapy or radiotherapy for TCC of bladder

          -  Participation in another clinical study with an investigational product during the
             last 6 months

          -  Any prior participation in a study involving an FGFR inhibitor.

          -  Concurrent enrolment in another clinical study, unless it is an observational
             (noninterventional) clinical study or during the follow-up period of an interventional
             study

          -  History of another primary malignancy except for:

               -  Malignancy treated with curative intent and with no known active disease ≥5 years
                  before the first dose of study drug and of low potential risk for recurrence

               -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
                  of disease

               -  Adequately treated carcinoma in situ without evidence of disease (e.g. cervical
                  cancer in situ)

          -  Receipt of the last dose of intravesical chemotherapy or biologic therapy ≤ 42 days (6
             weeks) prior to the first dose of study drug for patients who have received prior
             intravesical chemotherapy or biologic therapy (e.g. BCG)

          -  Any unresolved toxicity NCI CTCAE version 5.0 Grade ≥2 from previous anticancer
             therapy with the exception of alopecia, vitiligo, and the laboratory values defined in
             the inclusion criteria

          -  Patients currently receiving treatment with drugs that are known to be strong CYP3A4
             inducers or inhibitors, including anti-epileptic drugs.

          -  Use of medications that are known to prolong the QT interval and/or associated with a
             risk of torsade de pointes 7 days prior to the first dose of infigratinib.

          -  Use of amiodarone within 90 days prior to first dose of infigratinib.

          -  Use of medications that increase serum levels of calcium and/or phosphorus.

          -  Concurrent use of warfarin or other coumadin-derivative anticoagulants; heparin and/or
             low molecular-weight heparins are permitted.

          -  Inorganic phosphorus and/or total/ionized serum calcium outside normal limits prior to
             study entry.

          -  Have clinically significant cardiac disease, including any of the following:

               -  New York Heart Association (NYHA) Class ≥2B; subjects with known history or
                  current symptoms of cardiac disease, or history of treatment with cardiotoxic
                  agents, should have a clinical risk assessment of cardiac function using the NYHA
                  classification.

               -  Presence of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥2
                  ventricular arrhythmias, atrial fibrillation, bradycardia, or conduction
                  abnormality

               -  Unstable angina pectoris or acute myocardial infarction ≤3 months prior to first
                  dose of study drug

               -  QTcF >470 msec (males and females). Note: If the QTcF is >470 msec in the first
                  ECG, a total of 3 ECGs separated by at least 5 minutes should be performed. If
                  the average of these 3 consecutive results for QTcF is ≤470 msec, the subject
                  meets eligibility in this regard

               -  Known history of congenital long QT syndrome.

          -  Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
             Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone
             replacement therapy) is acceptable.

          -  Major surgical procedure (as defined by the Investigator) within 28 days prior to the
             first dose of infigratinib. NB: local surgery of isolated lesions for palliative
             intent is acceptable.

          -  History of allogeneic organ transplantation

          -  Current evidence of corneal or retinal disorder/keratopathy

          -  Uncontrolled intercurrent illness, including but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
             angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic
             gastrointestinal conditions associated with diarrhea, or psychiatric illness/social
             situations that would limit compliance with study requirement, substantially increase
             risk of incurring AEs or compromise the ability of the patient to give written
             informed consent

          -  Female patients who are pregnant or breastfeeding, or patients of reproductive
             potential who are not willing to employ effective birth control from screening to 90
             days after the last dose of infigratinib monotherapy.

          -  Known allergy or hypersensitivity to any of the study drugs or any of the study drug
             excipients

          -  Inability to swallow oral medications

          -  Judgement by the investigator that the patient is unsuitable to participate in the
             study and the patient is unlikely to comply with study procedures, restrictions and
             requirements.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Guru Sonpavde, MD, 617-632-2429, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04972253

Organization ID

21-162


Responsible Party

Sponsor-Investigator

Study Sponsor

Guru P. Sonpavde

Collaborators

 QED Therapeutics, Inc.

Study Sponsor

Guru Sonpavde, MD, Principal Investigator, Dana-Farber Cancer Institute


Verification Date

July 2021