Study Maintenance Regorafenib vs Placebo, no Progression Patients After I Line Chemotherapy Metas… (NCT03627728) | Clinical Trial Compass
CompletedPhase 2
Study Maintenance Regorafenib vs Placebo, no Progression Patients After I Line Chemotherapy Metastatic Gastric Cancer
Italy67 participantsStarted 2018-06-13
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
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)
What they're measuring
1
PFS1
Timeframe: 36 months
Trial details
NCT IDNCT03627728
SponsorGruppo Oncologico Italiano di Ricerca Clinica
✕. 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 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.