FUTIBATINIB for Solid tumor | Esophageal cancer | Pancreatic ductal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Provide written informed consent prior to any study-specific procedures and are willing to comply with all study procedures"}
• {"criterion_text":"- Have adequate organ function as exemplified in the protocol"}
• {"criterion_text":"- Able to take medications orally"}
• {"criterion_text":"- Cohort B only: Has archival tumor tissue available for submission to the central laboratory."}
• {"criterion_text":"- Women of child-bearing potential (WOCBP) must have a negative pregnancy test. Female patients are not considered to be of child-bearing potential if they are permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or are post-menopausal (no menses for 12 months without an alternative medical cause)"}
• {"criterion_text":"- Willing and able to comply with scheduled visits and study procedures"}
• {"criterion_text":"- Is ≥18 years of age at the time of informed consent (or meets the country’s regulatory definition for legal adult age)"}
• {"criterion_text":"- Histologically or cytologically confirmed, locally advanced, unresectable or metastatic carcinoma: a. Cohort A: Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ). b. Cohort B: Pancreatic ductal adenocarcinoma."}
• {"criterion_text":"- No prior systemic treatment for locally advanced, unresectable or metastatic EC (esophageal carcinoma) or PDAC (pancreatic ductal adenocarcinoma)."}
• {"criterion_text":"- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009). A lesion(s) situated in a previously irradiated area can be considered a target lesion(s) if progression has been demonstrated and the lesion(s) is considered measurable per RECIST 1.1 criteria"}
• {"criterion_text":"- ave documentation of PD-L1 CPS score (Cohort A only)."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1"}

Exclusion criteria

• {"criterion_text":"- Has locally advanced esophageal carcinoma or pancreatic cancer that is resectable or potentially curable with radiation therapy (as determined by local investigator)"}
• {"criterion_text":"- Has known hypersensitivity or severe reaction to any of the study drugs or their excipients, including severe reaction to fluoropyrimidine therapy."}
• {"criterion_text":"- Has received prior treatment with an anti-PD-1/PD-L1 or FGF/FGFR targeting drug, or any other agent directed to stimulatory or co-stimulatory T-cell receptor"}
• {"criterion_text":"- Has known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment"}
• {"criterion_text":"- Has had treatment as defined in the protocol within the specified time frame prior to the first dose of study treatment"}
• {"criterion_text":"- Has a serious illness or medical condition(s)"}
• {"criterion_text":"- Has a history or current evidence of calcium and phosphate homeostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (except commonly observed calcifications in soft tissues such as the skin, kidney, tendons, or vessels due to injury, disease, and aging in the absence of systemic mineral imbalance)"}
• {"criterion_text":"- Has current evidence of clinically significant retinal disorder as confirmed by ophthalmological examination"}
• {"criterion_text":"- Is pregnant or lactating female"}
• {"criterion_text":"- Have a complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥150ng/ml)."}
• {"criterion_text":"- Has some safety specific values defined in the protocol for patients selected to receive oxaliplatin."}
• {"criterion_text":"- Has an esophageal carcinoma or pancreatic cancer that is known to be eligible to receive approved targeted therapy (eg, HER-2 positive patients dMMR/MSI-high, germline BRCAmt)."}
• {"criterion_text":"- Has some specific symptoms defined in the protocol for patients selected to receive cisplatin"}
• {"criterion_text":"- Patients who have a persistent Grade ≥2 toxicity related to prior treatment."}
• {"criterion_text":"- Exclusion only applicable for France"}
• {"criterion_text":"- Exclusion only applicable for Germany"}
• {"criterion_text":"- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug"}
• {"criterion_text":"- Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody or RNA. Active Hepatitis C virus (HCV) is defined by a known positive Hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay"}
• {"criterion_text":"- Has an active autoimmune disease that has required systemic treatment in the past 2 years (that is, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (for example, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed"}
• {"criterion_text":"- Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis"}
• {"criterion_text":"- Has had an allogenic tissue/organ transplant"}
• {"criterion_text":"- Is unable to swallow tablets/capsules or has any disease or condition that may significantly affect gastrointestinal absorption of futibatinib (eg, inflammatory bowel disease, malabsorption syndrome, or prior gastric/bowel resection)"}
• {"criterion_text":"- Is judged by the investigator to be ineligible as a participant of the clinical study"}

Primary endpoints

• {"endpoint_text":"- Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment","definition_or_measurement_approach":"ORR assessed per RECIST v1.1 by investigator assessment"}

Secondary endpoints

• {"endpoint_text":"- Safety based on AEs, SAEs, dose modifications, clinical laboratory parameters, vital signs, electrocardiograms (ECGs), and ophthalmological exams","definition_or_measurement_approach":"Safety assessed by adverse events (AEs), serious adverse events (SAEs), dose modifications, labs, vital signs, ECGs, ophthalmologic exams"}
• {"endpoint_text":"- Duration of response (DoR) by investigator assessment","definition_or_measurement_approach":"DoR measured per investigator assessment"}
• {"endpoint_text":"- Disease control rate (DCR) by investigator assessment","definition_or_measurement_approach":"DCR assessed by investigator"}
• {"endpoint_text":"- Progression-free survival (PFS) by investigator assessment","definition_or_measurement_approach":"PFS assessed by investigator"}
• {"endpoint_text":"- 6-month PFS rate by investigator assessment","definition_or_measurement_approach":"6-month PFS rate assessed by investigator"}

Spain

Earliest CTIS Part Ii Submission Date

01-03-2024

Latest Decision Or Authorization Date

26-06-2025

Processing Time Days

483

Number Of Sites

2

Number Of Participants

5

France

Earliest CTIS Part Ii Submission Date

06-02-2024

Latest Decision Or Authorization Date

04-06-2025

Processing Time Days

484

Number Of Sites

2

Number Of Participants

5

Germany

Earliest CTIS Part Ii Submission Date

20-02-2024

Latest Decision Or Authorization Date

25-06-2025

Processing Time Days

491

Number Of Sites

2

Number Of Participants

5

Primary sponsor

Full Name

Taiho Oncology Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

case processing, regulatory submission and reg intelligence, CT SAE reconciliation (codes:12,15,8)

Name

Syneos Health Netherlands B.V.

Responsibilities

Clinical operations and other sponsor duties (codes:1,12,2,3,5,6,8)

Name

Medidata Solutions Inc.

Responsibilities

eClinical platform/vendor services (code:7)

Name

4g Clinical LLC

Responsibilities

Provision and configuration of IRT randomization and drug supply management (code:15); other IRT responsibilities (code:3)

Name

Fisher Clinical Services GmbH

Responsibilities

QP and distribution (code:15) and other supply responsibilities (codes:6,8)

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes:12,15 (case processing, regulatory submission and reg intelligence, CT SAE reconciliation),8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cenetron Diagnostics Ltd.","duties_or_roles":"15 (ctDNA kit build, processing, and storage)","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"codes:1,12,2,3,5,6,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"15 (Provision and configuration of IRT randomization and drug supply management),3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"15 (QP, distribution),6,8","organisation_type":"Pharmaceutical company"}