Clinical trial NCT01231581 (phase 2, status: completed)
Conditions: cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: gsk1120212, gemcitabine, placebo
SMILES: CN1C(=O)C(C)=C2N(C(=O)N(C3CC3)C(=O)C2=C1NC1=CC=C(I)C=C1F)C1=CC(NC(C)=O)=CC=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  18 years old or older

          -  Histologically or cytologically confirmed diagnosis of metastatic (Stage IV)
             adenocarcinoma of the pancreas with measurable or non-measurable disease per Response
             Evaluation Criteria in Solid Tumors (RECIST) 1.1

          -  Performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group
             (ECOG) scale

          -  All prior treatment related toxicities must be Common Terminology Criteria for Adverse
             Events (CTCAE) (Version 4.0) ≤ Grade 1 (except alopecia) at the time of randomization

          -  Adequate baseline organ function

          -  Able to swallow and retain orally administered medication and does not have any
             clinically significant gastrointestinal abnormalities that may alter absorption such
             as malabsorption syndrome or major resection of the stomach or bowels

        Exclusion Criteria:

          -  Prior systemic therapy (i.e., chemotherapy, immunotherapy, hormone therapy, , targeted
             therapy or any investigational anti-cancer drug) for metastatic pancreatic
             adenocarcinoma.

        (Prior treatment with 5-FU based or gemcitabine administered as a radiation sensitizer
        during and up to 4 weeks after radiation therapy is allowed. Prior systemic chemotherapy in
        the adjuvant setting is allowed ; however, prior therapy with gemcitabine is allowed only
        if tumor recurrence occurred at least 6 months after completing the last dose of
        gemcitabine)

          -  History of another malignancy. Exception: Subjects who have been disease-free for 5
             years, or subjects with a history of completely resected non-melanoma skin cancer or
             successfully treated in situ carcinoma are eligible. Subjects with second malignancies
             that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor
             if unsure whether second malignancies meet requirements specified above

          -  Any serious and/or unstable pre-existing medical (aside from malignancy exception
             above), psychiatric disorder, or other conditions that could interfere with subject's
             safety, obtaining informed consent or compliance to the study procedures, in the
             opinion of the Investigator or GSK Medical Monitor

          -  History of interstitial lung disease or pneumonitis

          -  History or current evidence / risk of retinal vein occlusion (RVO) or central serous
             retinopathy (CSR)

          -  Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression

          -  History of acute coronary syndromes (including unstable angina), coronary angioplasty,
             or stenting within the past 6 months