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Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05052801
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal Junction Adenocarcinoma Drug: Bemarituzumab Drug: mFOLFOX6 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
Actual Study Start Date : March 7, 2022
Estimated Primary Completion Date : August 18, 2025
Estimated Study Completion Date : August 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bemarituzumab with mFOLFOX6 Drug: Bemarituzumab
Intravenous (IV) infusion

Drug: mFOLFOX6
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.
Active Comparator: Placebo with mFOLFOX6 Drug: mFOLFOX6
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.

Drug: Placebo
IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to approximately 3.5 years ]
    Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Up to approximately 3.5 years ]
    PFS in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  2. Objective Response Rate (ORR) [ Time Frame: Up to approximately 3.5 years ]
    ORR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  3. Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to approximately 3.5 years ]
    Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests after first dose will be recorded as TEAEs.

  4. Overall Survival [ Time Frame: Up to approximately 3.5 years ]
    Overall survival in all randomized participants

  5. Progression-free Survival (PFS) [ Time Frame: Up to approximately 3.5 years ]
    PFS in all randomized participants

  6. Objective Response Rate (ORR) [ Time Frame: Up to approximately 3.5 years ]
    ORR in all randomized participants

  7. Duration of Response (DOR) [ Time Frame: Up to approximately 3.5 years ]
    DOR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  8. Disease Control Rate [ Time Frame: Up to approximately 3.5 years ]
    Disease Control Rate in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  9. Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  10. Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Baseline up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  11. Stomach Cancer Related Symptom Mean Subjective Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22) [ Time Frame: Up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  12. Change from Baseline in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22) [ Time Frame: Baseline up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  13. Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) [ Time Frame: Up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  14. Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) [ Time Frame: Baseline up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  15. Time to Deterioration in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22) [ Time Frame: Up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  16. Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score [ Time Frame: Up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  17. Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score [ Time Frame: Up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  18. Time to Deterioration in Physical Function Score as Measured by a Subscale of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Day 1 up to approximately 3.5 years ]
    Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

  19. Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma [ Time Frame: Day 1 up to approximately 3.5 years ]
  20. Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma [ Time Frame: Day 1 up to approximately 3.5 years ]
  21. Number of Participants with an Anti-bemarituzumab Antibody Formation [ Time Frame: Day 1 up to approximately 3.5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
  • Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
  • Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
  • Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
  • Participant has no contraindications to mFOLFOX6 chemotherapy

  • Adequate organ and bone marrow function:

    • absolute neutrophil count greater than or equal to 1.5 times 10^9/L
    • platelet count greater than or equal to 100 times 10^9/L
    • hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
    • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
    • calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
    • international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment

Exclusion Criteria:

  • Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
  • Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
  • Known human epidermal growth factor receptor 2 (HER2) positive
  • Untreated or symptomatic central nervous system (CNS) disease or brain metastases
  • Peripheral sensory neuropathy greater than or equal to Grade 2
  • Clinically significant cardiac disease
  • Other malignancy within the last 2 years (exceptions for definitively treated disease)
  • Chronic or systemic ophthalmological disorders
  • Major surgery or other investigational study within 28 days prior to first dose of study treatment
  • Palliative radiotherapy within 14 days prior to the first dose of study treatment
  • Evidence of or recent history (within 6 months) 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052801


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05052801    
Other Study ID Numbers: 20210096
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Bemarituzumab
FGFR2b Overexpression
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Bemarituzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents