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



Status:Recruiting
Conditions:Liver Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:July 14, 2014
End Date:October 18, 2019
Contact:QED Therapeutics
Email:clinicaltrials@QEDTx.com
Phone:650-231-4088

Use our guide to learn which trials are right for you!

A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy

This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor
activity in advanced or metastatic cholangiocarcinoma patients with Fibroblast Growth Factor
receptor (FGFR) genetic alterations.

Adult patients with histologically or cytologically confirmed advanced or metastatic
cholangiocarcinoma with 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. Approximately 55 adult patients over age 18, both male and female will be enrolled.
Of these 55 patients, 40 patients will have cholangiocarcinoma with identified FGFR2 gene
fusions and up to 15 patients may have other FGFR genetic alterations. 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.

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 or selective FGFR inhibitor

- 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.
We found this trial at
10
sites
New York, New York 10021
Principal Investigator: Maeve K. Lowery
Phone: 646-888-4329
?
mi
from
New York, NY
Click here to add this to my saved trials
Boston, Massachusetts 02114
Principal Investigator: Andrew Zhu
Phone: 617-724-9347
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bruxelles,
Click here to add this to my saved trials
Columbus, Ohio 43221
Principal Investigator: Sameek Roychowdhury
Phone: 614-293-9863
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Detroit, Michigan 48201
Principal Investigator: Philip A. Philip
Phone: 313-576-9385
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Milind Javle
Phone: 713-563-7757
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90033
Principal Investigator: Saeed Sadeghi
Phone: 310-582-6324
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Phoenix, Arizona 85054
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
San Francisco, California 94143
Principal Investigator: Robin Kate Kelley
Phone: +1 415 514 6220
?
mi
from
San Francisco, CA
Click here to add this to my saved trials