Study Comparing Bemarituzumab plus Chemotherapy with Placebo and Chemotherapy in Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression (FORTITUDE-101)
- Conditions
- Previously Untreated Advanced Gastric or Gastroesophageal JunctionCancer with FGFR2b overexpressionMedDRA version: 21.1Level: PTClassification code: 10017758Term: Gastric cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505457-40-00
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 516
Subject has provided informed consent prior to initiation of any study specific activities/procedures., Age =18 years (or legal adult age within country, whichever is older), Histologically documented gastric or GEJ adenocarcinoma (not amenable to curative therapy). Primary tumor location will be classified following the American Joint Committee on Cancer/Union for International Cancer Control [AJCC/UICC] 8th edition., Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy), FGFR2b = 10% 2+/3+ TC as determined by centrally performed IHC testing, based on tumor sample, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, Adequate organ function as follows: absolute neutrophil count = 1.5 x 109/L platelet count = 100 x 109/L hemoglobin = 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment aspartate aminotransferase and ALT < 3x upper limit of normal (ULN) (or < 5 x ULN if liver involvement). Total bilirubin < 1.5 x ULN (or < 2 x ULN if liver involvement; with the exception of subjects with Gilbert's disease) calculated or measured creatinine clearance (CrCl) of = 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) x Mass [kg]/[72 x Creatinine mg/dL]) (x 0.85 if female) international normalized ratio or prothrombin time (PT) < 1.5 x ULN except for subjects receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment, Measurable disease or non-measurable, but evaluable disease, according to RECIST v1.1., Subject has no contraindications to mFOLFOX6 chemotherapy
Untreated or symptomatic central nervous system (CNS) metastases and leptomeningeal disease Subjects with asymptomatic CNS metastases are eligible if clinically stable for at least 4 weeks and do not require intervention (including use of corticosteroids). Subjects with treated brain metastases are eligible provided the following criteria are met: Definitive therapy was completed at least 2 weeks prior to the first planned dose of study treatment (stereotactic radiosurgery at least 7 days prior to first planned dose of study treatment) At least 7 days prior to first dose of study treatment: any CNS disease is clinically stable, subject is off steroids for CNS disease (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs, History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids, Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing, History of other malignancy within the past 2 years, except: curatively treated non-melanoma skin malignancy cervical cancer in situ curatively treated uterine cancer stage I curatively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapy localized prostate cancer that has been treated surgically with curative intent and presumed cured, Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmic laser treatment, Prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, if completed more than 6 months prior to the first dose of study treatment Palliative radiotherapy is allowed, provided it has been completed more than 14 days prior to the first dose of study treatment All treatment-related toxicity needs to be resolved to grade = 1 prior to the first dose of study treatment, with the exception of alopecia or toxicities considered irreversible (defined as having been present and stable for > 21 days) which are not otherwise described in the exclusion criteria, Prior treatment with any selective inhibitor of the FGF-FGFR pathway, Currently receiving treatment in another investigational device or drug study, or within 28 days of first dose of study treatment or during this clinical study. Other investigational procedures while participating in this study are excluded, Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 9 months after the last dose of protocol-mandated therapy, Female subjects who are breastfeeding or plan to breastfeed while on study through 3 months after the last dose of protocol-mandated therapy, Female subjects planning to become pregnant while on study through 9 months after the last dose of protocol-mandated therapy, Unwillingness to avoid use of contact lenses during study treatment, Female subjects of childbearing potential with a positive pregnancy test assessed at screening and within 72 hours prior to first dose of study treatment, Male subjects with a female partner of childbearing potentia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method