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JOURNAL ONKOLOGIE – STUDIE

A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

Rekrutierend

NCT-Nummer:
NCT02150967

Studienbeginn:
Juli 2014

Letztes Update:
02.12.2020

Wirkstoff:
BGJ398 (infigratinib)

Indikation (Clinical Trials):
Cholangiocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
QED Therapeutics, Inc.

Collaborator:
-

Studienleiter

QED Therapeutics
Study Director
QED Therapeutics

Kontakt

Studienlocations
(3 von 37)

QED Investigative Site
Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ursula Koppenhoefer
Phone: +49 7071-298-4457
E-Mail: ursula.koppenhoefer@med.uni-tuebingen.de
» Ansprechpartner anzeigen
QED Investigative Site
85054 Phoenix
United StatesAbgeschlossen» Google-Maps
QED Investigative Site
10029 New York
United StatesAbgeschlossen» Google-Maps
QED Investigative Site
03080 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
QED Investigative Site
06351 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
QED Investigative Site
125367 Moscow
Russian FederationAbgebrochen» Google-Maps
QED Investigative Site
404133 Volzhsky
Russian FederationAbgebrochen» Google-Maps
QED Investigative Site
169610 Singapore
SingaporeAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Adult patients with histologically or cytologically confirmed advanced or metastatic

cholangiocarcinoma with FGFR2 gene fusions or translocations or other FGFR genetic

alterations who have evidence of radiologic progression following a cisplatin-and

gemcitabine-containing regimen for advanced disease or a gemcitabine-containing regimen for

those who are considered intolerant to cisplatin will be enrolled. Up to approximately 160

adult patients over age 18, both male and female will be enrolled. Three cohorts of patients

comprise the study population:

Cohort 1: patients with FGFR2 gene fusions or translocations and other FGFR genetic

alterations enrolled under the original protocol and amendment 1.

Cohort 2: patients with FGFR genetic alterations other than FGFR2 gene fusions or

translocations.

Cohort 3: patients with FGFR2 gene fusions or translocations who have received a prior FGFR

inhibitor.

All patients will receive oral BGJ398, once daily, on a three weeks on (21 days), one week

off (7 days) schedule. One treatment cycle will consists of 28 days.

Ein-/Ausschlusskriterien

Inclusion criteria:

- Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the

time of diagnosis.

Patients with cancers of the gallbladder or ampulla of Vater are not eligible.

- Patients must have received at least one prior regimen containing gemcitabine with or

without cisplatin for advanced/ metastatic disease. Patient should have evidence of

progressive disease following prior regimen, or if prior treatment discontinued due to

toxicity must have continued evidence of measurable or evaluable disease.

Exclusion criteria:

- Prior or current treatment with a MEK inhibitor (all cohorts), BGJ398/infigratinib

(all cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).

- insufficient organ function

- Absolutely Neutrophil Count (ANC) < 1,000/mm3 [1.0 x 109/L]

- Platelets < 75,000/mm3 [75 x 109/L]

- Hemoglobin < 109.0 g/dL

- Total bilirubin > 1.5x ULN

- Aspartate aminotransferase/glutamic oxaloacetic transaminase/GOT (AST/SGOT) and

Alanine aminotransferase/glutamic pyruvic transaminase/GPT (ALT/SGPT) > 2.5x ULN

(AST and ALT) > 5x upper limit of normal (ULN) in the presence of liver

metastases)

- Serum creatinine > 1.5x ULN and a calculated or measured creatinine clearance <

45 mL/min

- Inorganic phosphorus outside of normal limits

- Total and ionized serum calcium outside of normal limits

Other protocol-defined inclusion/exclusion criteria may apply.

Studien-Rationale

Primary outcome:

1. Overall response rate (ORR) (Time Frame - up to 24 months):
Overall response rate (ORR) is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), as per RECIST version 1.1.



Secondary outcome:

1. Overall survival (Time Frame - up to 24 months):
Overall Survival (OS) is defined as the time from the date of start of treatment to the date of death due to any cause.

2. Progression free survival (Time Frame - up to 24 months):
Progression free survival (PFS) is defined as the date of the start of treatment to the date of the event defined as the first documented progression or death due to any cause.

3. Best overall response (Time Frame - up to 24 months):
The best overall response will be summarized by the proportion of patients having a best overall response of PR, CR, stable disease (SD) or PD.

4. Disease control rate (Time Frame - up to 24 months):
Disease control rate (DCR) is the proportion of patients with a best overall response of CR or PR or stable disease (SD).

5. Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability (Time Frame - up to 24 months):
To characterize the safety and tolerability of single agent BGJ398 by the type, frequency and severity of AEs & SAEs.

6. Selected trough and 2-hr or 4-hr Plasma concentration profile (Time Frame - up to 12 months):
To determine selected trough and 2-hr or 4-hr plasma concentrations of BGJ398

Geprüfte Regime

  • BGJ398 (infigratinib):
    Capsule for oral use

Quelle: ClinicalTrials.gov


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