Etude : BAYER 18327 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : BAYER 18327

Nom :

Traitement : Métastasique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 07/02/2018
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Anetumab Ravtansine in Subjects With Mesothelin-expressing Advanced Solid Cancers and Different Stages of Concurrent Hepatic or Renal Impairment

Spécialité : Organes digestifs
Localisation : C18 - Tumeur maligne du côlon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Anetumab Ravtansine in Subjects With Mesothelin-expressing Advanced Solid Cancers and Different Stages of Concurrent Hepatic or Renal Impairment

1 arm / 4 cohorts:
--> Subjects with adequate hepatic and renal function (controls)
All subjects will receive anetumab ravtansine 6.5 mg/kg BW (body weight) once every three weeks

--> Subjects mild hepatic impairment (Child-Pugh Class A and eGFR [estimated glomerular filtration rate] ≥60 mL/min/1.73 m2)
All subjects will receive anetumab ravtansine 6.5 mg/kg BW (body weight) once every three weeks

--> Subjects with moderate hepatic impairment (Child-Pugh Class B and and eGFR ≥60 mL/min/1.73 m2)
All subjects will receive anetumab ravtansine 6.5 mg/kg BW (body weight) once every three weeks

--> Moderate renal function impairment will be assessed by eGFR <60 and ≥30 mL/min per 1.73 m2
All subjects will receive anetumab ravtansine 6.5 mg/kg BW (body weight) once every three weeks

Phase : I

Stade : NA

1, 2, 3, 4
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Male or female subjects aged ≥18 years
- Histologically or cytologically confirmed, locally advanced or metastatic solid cancers known to express mesothelin on the tumor cell surface (e.g. predominantly epithelial [>=50% tumor component] pleural or peritoneal mesothelioma, epithelial ovarian cancer [including the fallopian tube or primary peritoneal], adenocarcinoma of the pancreas, triple-negative adenocarcinoma of the breast, non-small-cell adenocarcinoma of the lung, endometrial cancer, serous uterine cancer, gastric cancer [including the gastro-esophageal junction], colon cancer, cholangiocarcinoma, thymic carcinoma, etc.). Subjects with resected primary cancers who have documented metastases or local recurrence are eligible.
- Subjects must have no standard therapy available, or have actively refused standard therapy
- Subjects must meet the criteria for one of the 4 treatment groups:
--> Group A: Adequate hepatic and renal function (controls)
--> Group B: Mild hepatic impairment, i.e. Grade A according to the Child-Pugh Classification (total score of 5 or 6) and adequate renal function
--> Group C: Moderate hepatic impairment, i.e. Grade B according to the Child-Pugh Classification (total score of 7, 8 or 9) and adequate renal function
--> Group D: Moderate renal impairment, i.e. eGFR (estimated glomerular filtration rate) <60 and ≥30 mL/min per 1.73 m2 and hepatic function better than, or equal to mild impairment according to the Child-Pugh Classification (total score ≤6)
- Adequate bone marrow function
- Life expectancy of at least 12 weeks
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 (control and mild hepatic impairment groups), or 0-2 (moderate hepatic impairment and moderate renal impairment groups)

Critères de non-inclusion : - Subjects who have a Pprevious or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated >3 years before the start of anetumab ravtansine
- Subjects who have new or progressive brain or meningeal or spinal metastases
- Subjects who have Gilbert's syndrome or other benign congenital hyperbilirubinemia or other benign congenital hyperbilirubinemia are not eligible for the mild or moderate hepatic impairment or moderate renal impairment groups.
- Subjects who have a history or current evidence of bleeding disorder, i.e. any hemorrhage/bleeding event of CTCAE (Common Terminology Criteria for Adverse Events) Grade ≥2 bleeding within 4 weeks before the start of anetumab ravtansine
Subjects who have a history or current evidence of Uuncontrolled cardiovascular disease or cardiovascular disease or hypertension.
- QTc interval >480 ms, heart rate ≥100 bpm or ≤45 bpm, LVEF (left ventricular ejection fraction) <50%
- Subjects with Ccorneal epitheliopathy or any eye disorder that may predispose the subjects to drug-induced corneal epitheliopathy or may interfere with diagnosis of treatment-emergent corneal epitheliopathy at the investigator's discretion in consultation with an ophthalmologist.
- Subjects who have received Ssystemic anticancer therapy (except pemetrexed, cisplatin, carboplatin and topical or intracavitary treatments with negligible absorption in systemic circulation ) within 4 weeks before the start of anetumab ravtansine, or within 5 half-lives of the anticancer agent before the start of anetumab ravtansine, whichever is longer. Mitomycin C or nitrosoureas must be excluded within 6 weeks before the start of anetumab ravtansine.
- Subjects who have received Rradiotherapy within 4 weeks before the start of anetumab ravtansine
- Use of drugs that, in the opinion of the investigator, have a strong potential for renal or hepatic toxicity within 2 weeks before the start of anetumab ravtansine until the EoT visit.Use of drugs with known renal or hepatic toxicity within 2 weeks before the start of anetumab ravtansine until the EoT (end of treatment) visit
- Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the start of anetumab ravtansine until the EoT visit
- Women who are pregnant or breast-feeding
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
Bayer
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Marie-Pierre GALAIS

TEC / ARC / IDE :
Sophie BUTT
s.butt@
baclesse.unicancer.fr

Ouverture de l'essai : CLOS

MAJ : 15/05/2018