HER2 negative locally advanced/metastatic gastric or gastroesophagel junction cancer. MedDRA version: 17.1 Level: PT Classification code 10063916 Term: Metastatic gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Stivarga
Product Name: Regorafenib
Pharmaceutical Form: Tablet
INN or Proposed INN: REGORAFENIB
CAS Number: 755037-03-7
Other descriptive name: REGORAFENIB
Concentration unit: mg milligr
Sponsors
Azienda Ospedaliero-Universitaria di Parma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male of female = 18 years of age Have an Eastern Cooperative Oncology Group performance status of 0 or 1 Diagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction HER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -) CR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy Measurable disease according to RECIST 1.1 criteria Normal bone marrow, liver, renal functionality Written informed consent Negative pregnacy test within 7 days before treatment start 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s Wort) Have used biologic response modifiers, such as G-CSF, within 3 weeks of study entry Have had prior treatment with regorafenib or any other VEGFR-targeting kinase inhibitor. Completed their last dose of chemotherapy more than 8 weeks, whichever came later, prior to randomization. Have had prior or concurrent cancer distinct in primary site or histology from GC or GJC within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non melanoma skin cancer, or superficial bladder tumors classified as noninvasive tumor (Ta), carcinoma in situ (Tis), or tumor invades lamina propria (T1). Have had systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and/or hormonal therapy within 4 weeks prior to initiation of study treatment. Have unresolved toxicity higher than National Cancer Institute-Common Terminology for Adverse Events version 4.0 (NCI-CTCAE v 4.0) Grade 1 attributed to any prior therapy/procedure, excluding alopecia and/or oxaliplatin-induced neurotoxicity = Grade 2 and hemoglobin = 9 g/dL as per inclusion criteria. Have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment. Are pregnant. Are breastfeeding. Are unable to swallow oral tablets (crushing of study treatment tablets is not allowed). Have congestive heart failure classified as New York Heart Association Class 2 or higher Have had unstable angina (angina symptoms at rest) or new-onset angina ? 3 months prior to screening. Have had a myocardial infarction ? 6 months prior to initiation of study treatment. Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin. Have uncontrolled hypertension (systolic blood pressure [SBP] ? 140 mmHg or diastolic blood pressure [DBP] ? 90 mmHg) despite optimal medical management. Have had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months prior to the initiation of study treatment. Have an ongoing infection with severity of Grade 2 or above (NCI-CTCAE v 4.0). Have a known history of human immunodeficiency virus infection. Have either active or chronic hepatitis B or C requiring treatment with antiviral therapy. Have a seizure disorder requiring medication. Have a history of organ allograft. Have evidence or history of any bleeding diathesis (including mild hemophilia), irrespective of severity. Have had a hemorrhage or a bleeding event ? Grade 3 (NCI-CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment. Have a nonhealing wound, ulcer, or bone fracture. Have renal failure requiring hemodialysis or peritoneal dialysis. Have dehydration ? Grade 1 (NCI-CTCAE v 4.0). Have interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained. Have persistent proteinuria > 3.5 g/24 hours measured by urine protein creatinine ratio from a random urine sample (? Grade 3, NCI-CTCAE v 4.0). Have any other serious or unstable illness, or medical, p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PFS-progression free survival;Secondary Objective: OS-overall survival, safety, RR-response rate, quality of life;Primary end point(s): PFS-progression free survival;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): OS-overall survival, safety, RR-response rate, quality of life;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Italy
Contacts
Public ContactUfficio Sperimentazioni Cliniche
UOC di Oncologia Medica, Azienda Ospedaliero-Universitaria di Parma
Outcome results
None listed