Physician

Asim Ali, MD

Study Coordinator

Vanessa Shaw, RN
484-526-6038

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Treatment Agent:Bemarituzumab

Synopsis: The purpose of the study is to test the safety, efficacy (possible usefulness), and tolerability of a new investigational compound, called FPA144, in combination with chemotherapy (a combination of 5-fluorouracil, oxaliplatin and leucovorin called mFOLFOX6) for the treatment of gastric and/or gastroesophageal cancer. FPA144 is an experimental drug being developed by Five Prime Therapeutics, Inc. (“FivePrime”), a biopharmaceutical company based in the United States of America (US). FivePrime is the study sponsor. FPA144 is not approved by the US Food and Drug Administration (FDA) or any other health authority in any country. It can only be given to patients as part of a clinical study like this one. FPA144 has been tested in a relatively small number of patients (as of March 20, 2017, a total of 64 patients have received at least 1 dose of FPA144). Therefore, information on the side effects, and efficacy of FPA144 in treating humans, is limited. Later in this form you will find a summary of the information currently available. This study consists of two phases, a Phase 1 and a Phase 3. Phase 1 of the study will be open to patients who have gastrointestinal cancer and whose doctor plans to administer at least two doses of a type of chemotherapy treatment called mFOLFOX6. Phase 3 of the study will be open to patients who have gastric or gastroesophageal cancer, have a tumor that is FGFR2b positive, and whose doctor plans to administer chemotherapy (mFOLFOX6) as therapy. The Phase 3 portion of the study will start after the Phase 1 portion is complete. Participant enrollment is limited to one of the two phases (Phase I or Phase 3). You are being asked to participate in the Phase 3 portion of the study.

The main goals of the Phase 3 portion of the study are to:

• Test the effect, good and/or bad, of FPA144, when given with mFOLFOX6, has on your disease compared to mFOLFOX6 combined with placebo.
• Test the safety of FPA144 when given with mFOLFOX6
• Test the amount of FPA144 you have in your blood at different times

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• Disease that is unresectable, locally advanced, or metastatic (not amendable to curative therapy)
• Understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) prior to any study-specific evaluation
• Life expectancy of at least 3 months in the opinion of the investigator
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Age ≥ 18 years at the time the ICF is signed
• In sexually active patients (women of childbearing potential and males), willingness to use 2 effective methods of contraception, of which 1 must be a physical barrier method (condom, diaphragm, or cervical/vault cap) until 6 months after the last dose of FPA144. Other effective forms of contraception include:
• Permanent sterilization (hysterectomy and/or bilateral oophorectomy, or bilateral tubal ligation with surgery, or vasectomy) at least 6 months prior to Screening
• Women of childbearing potential who are on stable oral contraceptive therapy or intrauterine or implant device for at least 90 days prior to the study, or abstain from sexual intercourse as a way of living
• Adequate hematological and biological function, confirmed by the following laboratory values within 96 hours prior to enrollment:
• Bone Marrow Function
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• Platelets ≥ 100 × 109/L
• Hemoglobin ≥ 9 g/dL
• Hepatic Function
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN); if liver metastases, then < 5 × ULN
• Bilirubin < 1.5 x ULN except in patients with Gilbert's disease
• Renal Function
• Calculated creatinine clearance using cockroft Gault formula ≥ 50 mL/min (see Appendix 1)
• INR or prothrombin time (PT) < 1.5x the ULN except for patients receiving anticoagulation, who must be on a stable dose of warfarin for 6 weeks prior to enrollment
• Measurable or non-measurable, but evaluable disease using RECIST v1.1
• Histologically or cytologically confirmed GI malignancy for which mFOLFOX6 is considered an appropriate treatment (e.g., gastric cancer [GC], colorectal carcinoma, pancreatic adenocarcinoma)
• Patient must be a candidate to receive at least 2 doses of mFOLFOX6 chemotherapy

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• Untreated or symptomatic central nervous system (CNS) metastases (CNS imaging not required). Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks and do not require intervention such as surgery, radiation, or any corticosteroid therapy for management of symptoms related to CNS disease
• Impaired cardiac function or clinically significant cardiac disease, including any of the following :
• Unstable angina pectoris
• Acute myocardial infarction
• New York Heart Association Class II-IV congestive heart failure
• Uncontrolled hypertension (as defined as ≥ 160/90 despite optimal medical management)
• Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
• Active coronary artery disease
• Fridericiaís corrected QT interval (QTcF) ≥ 480
• Peripheral sensory neuropathy ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
• Active infection requiring systemic treatment or any uncontrolled infection
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
• History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis)
• Evidence or history of bleeding diathesis or coagulopathy
• Radiotherapy
• Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the fibroblast growth factor (FGF)-FGFR pathway
• Ongoing adverse effects from prior systemic treatment > NCI CTCAE Grade 1 (with the exception of Grade 2 alopecia)
• Participation in another therapeutic clinical study or receiving any investigational agent within 28 days of enrollment or during this clinical study
• Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
• Known positivity for HER2 (as defined by a positive IHC test of 3+ or IHC of 2_ with fluorescent in situ hybridization [FISH])
• Major surgical procedures not permitted
• Women who are pregnant or breastfeeding (unless the patient is willing to interrupt breastfeeding during study treatment administration and then resume 6 months after study discontinuation); women of childbearing potential must not consider getting pregnant during the study
• Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including arterial thrombosis, or symptomatic pulmonary embolism)
• Presence of any other condition that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry in the study
• Known allergy, hypersensitivity or contraindication to components of the FPA144 formulation including polysorbate or to platinum-containing medications, 5-FU, or leucovorin
• History of prior malignancy, except (Criteria a through f):
• Curatively treated non-melanoma skin malignancy
• Cervical cancer in situ
• Curatively treated Stage I uterine cancer
• 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
• Solid tumor treated curatively more than 5 years previously without evidence of recurrence

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