Clinical Trial: Cancer

Quorum Novartis Signature Study (PRO00002525)

Full Name

Quorum Novartis Signature study, CBGJ398XUS04: Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 6 – BGJ398 for patients with tumors with FGFR genetic alterations.

Description

In this study, a complete dosing cycle is 28 days (21 days on the study drug with a 7 day rest).  If you agree to participate, you will take 2 capsules of BGJ398 125 mg (one 100 mg and one 25 mg capsule) once daily in the morning at approximately the same time (starting on day 1, cycle 1) every day.  Blood work will be done every week for the first cycle and then every 2 weeks for the second cycle, and then every 4 weeks for every additional cycle thereafter.  Prior to being administered study drug, the following test and procedures will be performed to see if you are eligible (screening) for the study:  Collect documentation of your FGFR pathway regulation status; collect demographic information; answer health and medication questions; physical examination; eye examination; check vital signs; collect height and weight; Check your daily living abilities; blood collection; urine collection; pregnancy test; electrocardiogram (ECG - measures the electrical activity of your heart); MUGA Scan or Echocardiogram; CT Scan or MRI; and obtain archival tumor sample or fresh biopsy.  Depending on what kind of tumor you have, you may require additional, tumor specific assessments.

Eligibility

Inclusion Criteria
  • Must be 18 years of age and older
  • Must have a confirmed diagnosis of a select solid tumor or hematologic malignancies and is in need of treatment because of progression or relapse
  • Must have progressive and measurable disease per RECIST 1.1 or other appropriate hematological response criteria
  • Must not have received prior treatment with BGJ398
  • Must not have acute or chronic pancreatitis
  • Must not have history and/or current evidence of renal or endocrine alterations of calcium/phosphate homeostasis
Doctor(s) Running This Study

Specialties

  • Hematology/Medical Oncology

Area of focus i

  • Gastrointestinal cancers
  • Malignant hematology

Affiliated with

LVPG Cliniciani

Accepting New Patients