A Phase 3 Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase I to be conducted prior to Phase 3
- Conditions
- Advanced Gastric and Gastroesophageal CancerMedDRA version: 21.0Level: PTClassification code 10004267Term: Benign gastric neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003507-22-IT
- Lead Sponsor
- FIVE PRIME THERAPEUTICS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 548
Phase 1 and Phase 3:
1. Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
2. Understand and sign an Institutional Review Board
(IRB)/Independent Ethics Committee (IEC)-approved ICF prior to any study-specific evaluation
3. Life expectancy of at least 3 months in the opinion of the investigator
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
5. Age =18 years at the time the ICF is signed
6. In sexually active patients (women of child bearing potential [WOCBP] 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
• WOCBP 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
7. Adequate hematological and biological function, confirmed by the following laboratory values within 96 hours prior to enrollment:
Bone Marrow Function
• ANC = 1.5 × 109/L
• Platelets = 100 × 109/L
• Hemoglobin = 9 g/dL
Hepatic Function
• AST and ALT < 3 × ULN; if liver metastases, then < 5 × ULN
• Bilirubin < 1.5 × ULN except in patients with Gilbert's disease
Renal Function
• Calculated CrCl using Cockroft Gault formula = 50 mL/min or estimated glomerular filtrate rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula =50 mL/min
8. INR or prothrombin time (PT) < 1.5 × the ULN except for patients receiving anticoagulation, who must be on a stable dose of warfarin for 6 weeks prior to enrollment
9. Measurable or non-measurable, but evaluable disease using RECIST v1.1
Please refer to protocol section 4 for the additional inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 502
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
Phase 1 and Phase 3:1. 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 2. Impaired cardiac function or clinically significant cardiac disease, including any of the following (Criteria a through g): a) Unstable angina pectoris = 6 months prior to enrollment b) Acute myocardial infarction = 6 months prior to enrollment c) New York Heart Association Class II-IV congestive heart failure d) Uncontrolled hypertension (as defined as = 160/90 despite optimal medical management) e) Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin f) Active coronary artery disease g) Fridericia's correction formula (QTcF) = 480 3. Peripheral sensory neuropathy = CTCAE Grade 2 4. Active infection requiring systemic treatment or any uncontrolled infection =14 days prior to enrollment 5. Known human immunodeficiency virus (HIV) or acquired
immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection 6. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) 7. Evidence or history of bleeding diathesis or coagulopathy
8. Radiotherapy = 28 days of enrollment. Patients must be recovered from all acute radiotherapy-related toxicities. No radiopharmaceuticals (strontium, samarium) within 8 weeks of enrollment 9. Prior treatment with any selective inhibitor (eg, AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway
Please refer to protocol section 4 for the additional exclusion criteria (included the changes related to the amendment).
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