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Biotech / Medical : Incyte (INCY)
INCY 57.10+0.4%May 17 4:00 PM EDT

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To: tuck who wrote (3196)10/21/2018 12:13:50 PM
From: software salesperson   of 3202
here you go, tuck.

1) Primary bile duct cancer is uncommon in the United States. Each year, an estimated 8,000 people in the United States are diagnosed with bile duct cancer. The average age people are diagnosed with intrahepatic bile duct cancer is 70. For extrahepatic bile duct cancer, the average age at diagnosis is 72.The number of new cases of bile duct cancer is increasing, mostly due to rising rates of intrahepatic bile duct cancer. The reason for this increase is not known. It may be due to the use of more accurate tests to diagnose this type of cancer. Previously, intrahepatic bile duct cancer may have been thought to be a different type of cancer.

In some parts of the world, a parasite called a liver fluke can infect the bile duct and cause cancer. Liver flukes are very common in Asia, and bile duct cancer is more common in this part of the world. Also, gallstones and inflammatory conditions of the digestive tract, such as ulcerative colitis or an associated condition called Primary Sclerosing Cholangitis (PSC), increase the risk of bile duct cancer. PSC is an autoimmune disease in which the body's immune system attacks the bile ducts and causes scarring. See the Risk Factors section for more information.

The 5-year survival rate tells you what percent of people live at least 5 years after the cancer is found. Percent means how many out of 100. The 5-year survival rate for people with early-stage extrahepatic bile duct cancer is 30%. If the cancer has spread to the regional lymph nodes, the 5-year survival rate is 24%. If the cancer has spread to a distant part of the body, the 5-year survival rate is 2%.

For people with early-stage intrahepatic bile duct cancer, the 5-year survival rate is 15%. If the cancer has spread to the regional lymph nodes, the 5-year survival rate is 6%. If the cancer has spread to a distant part of the body, the 5-year survival rate is 2%.

It is important to remember that statistics on the survival rates for people with bile duct cancer are an estimate. The estimate comes from annual data based on the number of people with this cancer in the United States. Also, experts measure the survival statistics every 5 years. So the estimate may not show the results of better diagnosis or treatment available for less than 5 years. People should talk with their doctor if they have any questions about this information. Learn more about understanding statistics.

Source: American Cancer Society website.


Brief Summary:
The purpose of this study is evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.

Inclusion Criteria:

Histologically or cytologically confirmed cholangiocarcinoma.Radiographically measurable or evaluable disease per RECIST v1.1.Tumor assessment for FGF/FGFR gene alteration status.Documented disease progression after at least 1 line of prior systemic therapy.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.Life expectancy = 12 weeks.

Exclusion Criteria:

Prior receipt of a selective FGFR inhibitor.History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.


Brief Summary:
This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of ARQ 087 by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2 gene fusions (by FISH performed by the central laboratory) and who received at least one prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of ARQ 087 capsule

Inclusion Criteria:

Signed written informed consent granted prior to initiation of any study-specific procedures18 years of age or olderHistologically or cytologically confirmed locally advanced, inoperable (where surgery is not indicated due to disease extension, co-morbidities, or other technical reasons), or metastatic iCCA or mixed histology tumors (combined hepatocellular-cholangiocarcinoma [cHCC-CCA])FGFR2 gene fusion status confirmed by NGS or FISH testing

Test positive by FISH by the central laboratory designated by the SponsorHave FGFR2 gene fusion documented by a local or central laboratory using standard protocols and approved by local IRB/EC, by CLIA or other similar agency. If the FGFR2 gene fusion is identified by a laboratory other than the Sponsor's central laboratory, then archival and/or recent tissue biopsy samples or a tissue block suitable for genetic testing must be available for confirmatory testing by FISH by the Sponsor's central laboratory. If a subject has documentation from the central laboratory indicating that they test negative for FGFR2 gene fusion, that subject may not be enrolled in the study.Received at least one regimen of prior systemic therapy and then experienced documented radiographic progression or was not able to tolerate prior systemic therapy.

If the subject received at least 4 cycles of systemic therapy and no measurable tumor reduction compared to the previous scan is observed, such subject can be enrolledIf the subject received immunotherapy, the documented radiographic disease progression is requiredMeasurable disease by RECIST version 1.1ECOG performance status = 1Adequate organ functions as indicated by the following laboratory values (based on screening visit values from the central laboratory).


Hemoglobin (Hgb) = 9.0 g/dLAbsolute neutrophil count (ANC) = 1.5 x 109/LPlatelet count = 75 x 109/LInternational normalized ratio (INR) 0.8 to upper limit of normal (ULN) or = 3 for subjects receiving anticoagulant therapy such as Coumadin or heparinHepatic

Total bilirubin = 2 x ULNAST and ALT = 3 ULN (= 5 x ULN for subjects with liver metastases)Albumin = 2.8 g/dLRenal

Serum creatinine = 1.5 x ULNCreatinine clearance of = 60 mL/min as estimated by the Cockcroft-Gault equationMale or female subjects of child-producing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after the last dose of ARQ 087

Exclusion Criteria:

Systemic anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ARQ 087Major surgery, locoregional therapy, or radiation therapy within four weeks of the first dose of ARQ 087Previous treatment with any FGFR inhibitor (e.g., ponatinib, dovitinib, nintedanib, AZD4547, NVP-BGJ398, LY2784455, BAY1163877)

- Subjects who received less than four weeks of therapy and were unable to continue therapy due to toxicity will be allowed to participate

Unable or unwilling to swallow the complete daily dose of ARQ 087 capsulesClinically unstable central nervous system (CNS) metastases (to be eligible, subjects must have stable disease = 3 months, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and/or have CNS metastases well controlled by low-dose steroids, anti-epileptics, or other symptom-relieving medications)Current evidence of corneal or retinal disorder, including but not limited to bullous/band keratopathy, keratoconjunctivitis, corneal abrasion, inflammation/ulceration, confirmed by ophthalmologic examinationConcurrent uncontrolled or active hepatobiliary disorders, untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, biloma or abscess (to be eligible, the subjects have to be treated and disorders/complications should be resolved within 2 weeks prior to the first dose of ARQ 087)History of significant cardiac disorders:

Myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association (NYHA) classification within 6 months of the first dose of ARQ 087 (MI that occurred > 6 months prior to the first dose of ARQ 087 will be permitted)QTcF >500 msec (males or females)Significant gastrointestinal disorder(s) that could, in the opinion of the Investigator, interfere with the absorption, metabolism, or excretion of ARQ 087 (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)Previous malignancy within 2 years of the first dose of ARQ 087, except curatively treated or low grade malignancies such as non-melanoma skin cancer, carcinoma in-situ of the breast, cervix, and superficial bladder tumorsConcurrent uncontrolled illness not related to cancer, including but not limited to:

Psychiatric illness/substance abuse/social situation that would limit compliance with study requirementsKnown uncontrolled human immunodeficiency virus (HIV) infectionBlood or albumin transfusion within 5 days of the blood draw being used to confirm eligibilityPregnant or breast feeding
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