Pan FGFR Kinase Inhibitor BGJ398 and Combination Chemotherapy in Treating Patients With Untreated Metastatic Pancreatic Cancer

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Colon Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Rectal Adenocarcinoma, Stage III Pancreatic Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IV Pancreatic Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

In brief

This phase Ib/II trial studies the side effects and best dose of pan fibroblast growth factor receptor (FGFR) kinase inhibitor BGJ398 when given together with fluorouracil, irinotecan hydrochloride and oxaliplatin (combination chemotherapy) in treating patients with untreated pancreatic cancer that has spread to another place in the body. Pan FGFR kinase inhibitor BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pan FGFR kinase inhibitor BGJ398 together with fluorouracil, irinotecan hydrochloride and oxaliplatin may be a better treatment for pancreatic cancer.

Key facts

Study ID

NCT02575508

Run by

Roswell Park Cancer Institute

People needed

0

Last updated by the study team

2016-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase Ib: Histologically or cytologically confirmed adenocarcinoma of the pancreas, colon or rectum which disease is advanced (defined as not surgically curable) or metastatic in whom combination treatment using fluorouracil, oxaliplatin and irinotecan is a rational option
• All patients must consent to provide archival tumor samples; non-availability of evaluable tumor samples does not exclude patient from the study
• Phase II: Patients with histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that have not received systemic chemotherapy for advanced or metastatic disease; the definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data
• Phase II: The initial 20 patients must have evaluable baseline tumor samples; evaluable samples are defined as those obtained by core biopsy or surgical resection and amendable to histological analysis; samples obtained by fine needle aspiration biopsy are not considered evaluable; patients who do not have evaluable archival tumor samples must consent to a tumor core biopsy prior to starting study treatment and, patients who consent to the baseline tumor biopsy will be eligible to receive study treatment irrespective of whether the samples obtained are evaluable
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
• Phase Ib: Have evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• Phase II: Have at least 1 metastatic lesion other than the primary pancreatic tumor that is evaluable per RECIST 1.1 criteria; lesions previously irradiated are not considered evaluable
• Absolute neutrophil count (ANC) >= 1,500 cells/mm\^3 (International System of Units [SI] units 1.5 x 10\^9/L)
• Platelets >= 100,000 cells/mm\^3 (SI units 100 x 10\^9/L)
• Hemoglobin >= 9.0 g/dL (SI units 90 g/L)
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 3 x ULN; in patients with known hepatic involvement, AST and ALT =< 5 x ULN are allowed
• Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation
• International normalized ratio (INR) =< 1.5
• Inorganic phosphorus =< ULN
• Ionized calcium =< ULN
• Ability to swallow and retain oral medication
• Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if…

• Phase II: Patient who recurs with metastatic disease =< 6 months of completing adjuvant chemotherapy after curative-intent surgical resection is not eligible; patients who recur with metastatic disease > 6 months after completion of adjuvant chemotherapy are eligible
• Phase II: Patients that previously received systemic chemotherapy for metastatic or advanced pancreatic adenocarcinoma are not eligible
• Phase II: Diagnosis of any second malignancy within the last 3 years except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma or in-situ cervical carcinoma
• Patients with clinically significant ascites requiring paracentesis on 2 or more occasions within 4 weeks prior to start of study treatment
• Known hypersensitivity to BGJ398, fluorouracil, oxaliplatin, irinotecan or to any of the excipients
• Homozygous UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 (i.e. 7 TA repeats) gene alleles; the UGT1A1 test should be conducted per local institutional practice
• Palliative radiation treatment (e.g., pain control, bony lesions at risk of fracture) completed =< 2 weeks of starting study treatment; patient will be eligible if palliative radiotherapy is completed > 2 weeks from the start of study treatment and has recovered from radiotherapy toxicities
• Pulmonary embolus or thrombosis of the deep venous system (deep vein thrombosis [DVT]) within 2 weeks of starting study treatment; patients who had a history of thromboembolic disease should be stable on therapeutic anticoagulation using low molecular weight (LMW) heparin for at least 2 weeks prior to the start of study treatment; use of warfarin (or derivatives) is not allowed at the start of study treatment
• Patients with known symptomatic brain metastases requiring steroids and/or antiepileptic therapy; patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study treatment, and have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable; patients with leptomeningeal involvement are excluded
• Current evidence of corneal or retinal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination
• Prior FGFR inhibitor therapy
• History or current evidence of:
• Tissue calcification including, but not limited to, the soft tissue, kidneys, intestines, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification
• Endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc
• Patients who are currently receiving or consuming
• Medications that are known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) =< 14 days of starting study treatment
• Medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes =< 7 days prior to start of study treatment
• Amiodarone =< 180 days prior to start of study treatment
• Grapefruit, grapefruit juice, pomegranates, star fruits, Seville oranges or products =< 7 days prior to start of study treatment
• Warfarin (or derivatives)
• Uncontrolled intercurrent illness including, but not limited to,
• Ongoing or active infection
• Psychiatric illness/social situations that would limit compliance with study requirements
• Clinically significant cardiac disease including any of the following:
• Congestive heart failure requiring treatment (New York Heart Association grade >= 2), left ventricular ejection fraction (LVEF) < 50% as determined by multi gated acquisition scan (MUGA) scan or echocardiogram

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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