Phase II Study of Regorafenib as Maintenance Therapy (NCT03793361) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Regorafenib as Maintenance Therapy
France127 participantsStarted 2019-05-15
Plain-language summary
Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy.
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:
* Age ≥18 years
* Histologically proven soft tissue sarcoma including leiomyosarcoma, synovial sarcoma and other sarcomas
* Patients in partial response or stable disease after 6 cycles of doxorubicin-based first-line chemotherapy for metastatic/locally advanced soft tissue sarcoma
* Metastatic/locally advanced disease not amenable to surgical resection with curative intent
* Eastern Cooperative Oncology Group (ECOG) Performance Status =0 or 1
* Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST 1.1.
* Available tumor tissue for translational research program
* Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:
* Absolute neutrophil count (ANC) ≥1,500/mm3
* Platelets ≥100,000/mm3
* Hemoglobin ≥9.0 g/dL
* Serum creatinine ≤1.5 x upper limit of normal (ULN)
* Glomerular filtration rate (GFR) ≥30 ml/min/1.73m2
* AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer)
* Bilirubin ≤1.5 X ULN
* Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)
* Lipase ≤1.5 x ULN
* Spot urine must not show 1+ or more protein in urine or the patient will require a repeat urine analysis. If repeat urinanalysis shows 1+ protein or more, a 24-hour urine collection will be required and must show total protein excretion \<1000 mg/24 hours
* INR/PTT ≤1.5 x ULN (Patients who are therapeuti…
What they're measuring
1
To assess the efficacy of regorafenib compared to placebo
Timeframe: from the date of randomization to the date of first observed disease progression (according to RECIST 1.1 criteria) or death from any cause, up to 12 months after the beginning of the treatment