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CFGF401X2101
Stand 29.07.2020 12:07

Diese Studie wird von der Early Clinical Trial Unit ( ECTU ) der Studienambulanz Hämatologie/Onkologie durchgeführt.

A phase I/II, multicenter, open-label study of oral FGF401 in adult patients with hepatocellular carcinoma or solid malignancies characterized by positive FGFR4 and KLB expression

NCT-Nummer:

[--]*

EudraCT-Nummer:

2014-002929-35 ( EU Clinical Trials Register )

Studienstatus:

Im Followup (Rekrutierung geschlossen)

Rekrutierung:

09 Mar 2016 03 Jul 2018

Studiendesign:

Phase: I/II , Studientyp: Therapeutisch , Peer Reviewed: Ja , IIT: Nein , Multizentrisch , International

Therapielinie:

[--]*

Patientenalter:

Adults (18-64 years), Elderly (>=65 years) EU Clinical Trials Register Stand: 16.06.2016 16:28

Indikation:

Hepatozelluläres Karzinom

Anatomic Site:

Liver

Klinik / Organisation:

Interdisziplinäres Studienzentrum mit Early Clinical Trial Unit ( Universitätsklinikum Würzburg ), Medizinische Klinik II, Schwerpunkt Hepatologie ( Med. II, Universitätsklinikum Würzburg )

Sponsor:

Novartis Pharma Arzneimittel GmbH
Roonstr.25
D 90429 Nürnberg

LKP:

Prof. Dr. med. Martin Schuler
Universitätsklinikum Essen
Klinik für Innere Medizin
Hufelanstr. 55
45122 Essen

Diese Studie wird von der Early Clinical Trial Unit ( ECTU ) der Studienambulanz Hämatologie/Onkologie durchgeführt.

Hauptprüfer:

Herr Prof. Dr. Andreas Geier (Universitätsklinikum Würzburg)

Stellvertreter:

Frau PD Dr. Barbara Deschler-Baier (Universitätsklinikum Würzburg)
1. Patients (male or female) ≥ 18 years of age
2. ECOG Performance Status ≤ 1
3. Presence of at least one measurable lesion according to RECIST v1.1.
4. Patients with confirmed positive expression of FGFR4 and KLB at pre-screening.
5. For HCC patients: the diagnosis must be made based on AASLD Guidelines with confirmed stage C advanced HCC (BCLC staging classification). Current cirrhotic status of Child-Pugh class A (5-6 points), with no encephalopathy and/or ascites.
6. Phase I: Patients with HCC or advanced solid tumors, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
7. Phase 2: HCC patients previously treated with sorafenib for advanced HCC with documented disease progression during or after discontinuation of sorafenib treatment, or intolerance to sorafenib treatment.

Other protocol-defined inclusion criteria may apply.
1. Previous treatment with a FGF19-FGFR4 targeting therapy.
2. For HCC patients in Phase II part: any previous systemic anti-cancer therapies other than sorafenib or any anti-cancer therapy (including locoregional therapy) after disease progression during or after sorafenib treatment.
3. Ongoing active diarrhea requiring medications (e.g. BAS, loperamide)
4. Irritable bowel syndrome with signs/symptoms and requires medications
5. Symptomatic CNS metastases which are neurologically unstable or requiring increasing doses of steroids to control their CNS disease.
6. Patient having out of range laboratory values defined as:
• Hematology
Hemoglobin ≤ 9 g/dL (SI Units: 90 g/L)
Platelet count < 75000/mm3
Absolute neutrophil count (ANC) < 1500/mm3
• Chemistry
Total bilirubin ≥ 2 mg/dL
AST and/or ALT > 3 x ULN
Serum creatinine > 1.5 x ULN and/or creatinine clearance ≤ 45 mL/min
• Coagulation: PT ≥ 4 seconds or INR ≥ 1.7
7. Unable to stop any prohibited medications, including CYP1A2, CYP2C9 and CYP3A substrates with a narrow therapeutic index, long acting proton pump inhibitors, and strong BSEP efflux transporter inhibitors.

Other protocol-defined exclusion criteria may apply.