Clinical trial NCT02155088 (phase 1, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: byl719, gemcitabine, (nab)-paclitaxel
SMILES: [H][C@]1(CCCN1C(O)=NC1=NC(C)=C(S1)C1=CC(=NC=C1)C(C)(C)C(F)(F)F)C(O)=N, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C
Eligibility criteria:

        Inclusion Criteria:

          -  Patient is able to swallow and retain oral medication

          -  Histologically documented diagnosis of pancreatic adenocarcinoma.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Required baseline laboratory status according to protocol document

        Exclusion Criteria:

          -  Prior sensitivity or intolerance to PI3K inhibitors

          -  Potential participants with central nervous system (CNS) involvement may participate
             if the patient is: >/= 4 weeks from prior therapy completion (including radiation
             and/or surgery) to starting the study treatment; Clinically stable with respect to the
             CNS tumor at the time of screening; Not receiving steroid therapy.

          -  Prior treatment with any cytotoxic chemotherapy for treatment of pancreatic cancer
             except as an adjuvant therapy. Should not have received gemcitabine within 6 months of
             starting the study treatment. 5-Fluorouracil or radiation treatment should be received
             more than 4 weeks prior to receiving the study drug.

          -  Potential participants who have received radiotherapy ≤ 4 weeks prior to starting
             study drugs, with exception of palliative radiotherapy, who have not recovered from
             side effects of such therapy to baseline or Grade ≤ 1 and/or from whom ≥ 30% of the
             bone marrow was irradiated.

          -  Potential participants who have undergone major surgery ≤ 4 weeks prior to starting
             study treatment or who have not recovered from side effects of such procedure.

          -  Have received investigation agent within 30 days prior to enrollment

          -  Clinically significant cardiac disease or impaired cardiac function

          -  QT interval adjusted according to Fredericia (QTcF) > 480 msec on screening ECG

          -  Potential participants with diabetes mellitus requiring insulin treatment and/or with
             clinical signs or with fasting plasma glucose (FPG)> 140 mg/dL or history of
             documented steroid-induced diabetes mellitus.

          -  Any other condition that would, in the Investigator's judgment, preclude participation
             in the clinical study due to safety concerns or compliance with clinical study
             procedures, e.g. infection/inflammation, intestinal obstruction, unable to swallow
             oral medication, social/psychological complications.

          -  Impaired GI function or GI disease that may significantly alter the absorption of oral
             BYL719 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea,
             malabsorption syndrome, or small bowel resection).

          -  Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis
             (i.e. quantifiable hepatitis B virus [HBV]-DNA and/or positive HbsAg, quantifiable
             hepatitis C virus [HCV]-RNA).

          -  Known positive serology for human immunodeficiency virus (HIV)

          -  Known severely impaired lung function (spirometry and diffusing capacity of lung for
             carbon monoxide[DLCO] 50% or less of normal and O2 saturation 88% or less at rest on
             room air).

          -  Currently receiving warfarin or other coumarin derived anti-coagulant, for treatment,
             prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH),
             or fondaparinux is allowed

          -  Currently receiving treatment with drugs known to be strong inhibitors or inducers of
             isoenzyme CYP3A. Must have discontinued strong inducers for at least one week and must
             have discontinued strong inhibitors before the start of treatment. Switching to a
             different medication prior to starting study treatment is allowed.

          -  Has a history of non-compliance to medical regimen or inability to grant consent

          -  Currently receiving medication with a known risk of prolonging the QT interval or
             inducing Torsades de Pointes (TdP) and the treatment cannot either be discontinued or
             switched to a different medication prior to starting study drug treatment

          -  History of another malignancy requiring active treatment within 2 years prior to
             starting study treatment, except cured basal cell carcinoma of the skin or excised
             carcinoma in situ of the cervix.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)

          -  Participant who does not apply highly effective contraception during the study and
             through 12 weeks after final dose of study treatment