Etude : REACH-2 / I4T-MC-JVDE

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : REACH-2 / I4T-MC-JVDE

Situation thérapeutique :

Traitement :

Cadre réglementaire : RIPH2

Dernière MÀJ : 19/01/2021
CIM10 - Localisation(s)
Informations principales
Titre : A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (REACH-2)

Spécialité : Organes digestifs
Localisation : C22 - Tumeur maligne du foie et des voies biliaires intrahépatiques
Informations complémentaires
Schéma : Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib

2 arms:
- Experimental: Ramucirumab
8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
- Placebo Comparator: Placebo
Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.

Phase : III

Stade : NA

Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - A diagnosis of HCC based on histopathologic findings, or a diagnosis of cirrhosis and a tumor with classical HCC imaging characteristics.
- Prior sorafenib treatment for at least 14 days and discontinuation of sorafenib ≥14 days prior to randomization.
- Radiographic disease progression during or after sorafenib therapy or discontinuation of sorafenib because of intolerance.
- Sorafenib was the only systemic therapy for HCC.
- ≥1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 that has not been previously treated with locoregional therapy. A participant with a lesion(s) that has previously been treated with locoregional therapy is also eligible, if the lesion has documented progression after locoregional treatment and is measureable.
- Child-Pugh score <7 (Child-Pugh Class A).
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy.
- Baseline AFP ≥400 nanograms/milliliter.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Resolution of all clinically significant toxic effects of prior therapy.
- Total bilirubin ≤1.5 times upper limit of normal value (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤5 × ULN.
- Creatinine clearance ≥60 milliliters/minute.
- Urinary protein is ≤1+ on dipstick or routine urinalysis or 24-hour urine demonstrating <1 gram of protein.
- Absolute neutrophil count ≥1.0 × 10^9/Liter, hemoglobin ≥9 grams/deciliter, and platelets ≥75 × 10^9/Liter.
- International Normalized Ratio (INR) ≤1.5 and a partial thromboplastin time (PTT) ≤5 seconds above the ULN.
- Surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method.
- If a woman of childbearing potential, a negative serum pregnancy test prior to randomization.
- Willing to provide blood for research.

Critères de non-inclusion : - Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- Concurrent malignancy. Participants with carcinoma in situ of any origin and participants with prior malignancies in remission may be eligible with sponsor approval.
- Previous brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
- History of or current hepatic encephalopathy or clinically meaningful ascites.
- Ongoing or recent hepatorenal syndrome.
- Liver transplant.
- Previous systemic therapy with vascular endothelial growth factor (VEGF) pathway inhibitors other than sorafenib for treatment of HCC.
- Hepatic locoregional therapy following sorafenib or within 28 days prior to randomization.
- Major surgical procedure, traumatic injury, non-healing wound, or peptic ulcer ≤28 days prior to randomization.
- Placement of a subcutaneous venous access device within 7 days prior to the first dose of study treatment unless the procedure is judged of low risk of bleeding.
- Enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or in medical research judged not to be scientifically or medically compatible with this study.
- Discontinued from study treatment from another clinical trial within 28 days prior to randomization.
- Known allergy to any of the treatment components.
- Uncontrolled hypertension.
- Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, <6 months prior to randomization.
- Any bleeding episode considered life-threatening, or any Grade 3 or 4 gastrointestinal bleeding episode in the 3 months prior to randomization requiring intervention.
- Esophageal or gastric varices that require intervention or represent high bleeding risk. Participants with evidence of portal hypertension or prior bleeding must have had endoscopic evaluation within 3 months prior to randomization.
- Gastrointestinal perforation or fistulae within 6 months prior to randomization.
- Symptomatic congestive heart failure (New York Heart Association II-IV), unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia.
- Pregnant or breast-feeding.
Any medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. Conditions include but are not limited to:
-> Human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
-> Active or uncontrolled clinically serious infection. (Participants with chronic viral hepatitis are eligible.)
-> Ongoing or recent history of drug abuse.
-> Uncontrolled hereditary or acquired thrombotic or bleeding disorder.
- Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
- Therapeutic dose anticoagulation with warfarin, low molecular-weight heparin, or similar agents.
- Chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. Aspirin at doses up to 100 milligrams/day is permitted.
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :


Statut de l'essai : CLOS

MAJ : 13/11/2017