Study Maintenance Regorafenib vs Placebo, no Progression Patients After I Line Chemotherapy Metastatic Gastric Cancer

NCT03627728 | Completed Phase 2 DMC

• 1 other identifier: GOIRC-05-2016
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double-blind, placebo-controlled, multicenter Phase-II study. Approximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups: Arm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• PFS1

  Progression free survival will be calculated for all patients from the date of randomization until the date PD or death is first reported.

  36 months

Secondary Outcomes (6)

• OS

  36 months

• PFS2

  36 months

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability

  36 months

• Response Rate

  36 months

• quality of life To compare the patient treatment-related symptoms

  up to 8 months

Study Arms (2)

regorafenib

EXPERIMENTAL

Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease

Drug: Regorafenib

placebo

PLACEBO COMPARATOR

Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease

Other: placebo

Interventions

Regorafenib DRUG

regorafenib/placebo

Also known as: stivarga

regorafenib

placebo OTHER

regorafenib/placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male of female ≥ 18 years of age
• Have an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment
• Diagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
• HER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -)
• Locally advanced/metastatic gastric or gastroesophageal junction cancer
• CR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy
• Measurable disease according to RECIST 1.1 criteria
• Have adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:
• Total bilirubin 1.5 times the upper limit of normal (ULN)
• Alanine aminotransferase and aspartate aminotransferase 3 times the ULN
• Lipase 1.5 times the ULN
• Serum creatinine 1.5 times the ULN
• Glomerular filtration rate 30 mL/min/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula
• International normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.
• Platelet count 100,000 /mm3, hemoglobin 9 g/dL, absolute neutrophil count 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors

You may not qualify if:

• 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, no-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 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.

Sponsors & Collaborators

• Gruppo Oncologico Italiano di Ricerca Clinica: lead
• Bayer: collaborator

Study Sites (1)

Struttura Complessa di OncologiaIRCCS- Istituto in Tecnologie Avanzate e Modelli Assistenziali in Oncologia Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Carmine Pinto, MD

  Gruppo Oncologico Italiano di Ricerca Clinica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: August 13, 2018
• Study Start: June 13, 2018
• Primary Completion: June 21, 2022
• Study Completion: October 31, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)