A Study of LY2090314 in Patients With Advanced or Metastatic Cancer
Condition: Advanced Cancer
MeSH terms: Neoplasm Metastasis
Intervention: LY2090314; pemetrexed; Carboplatin; ranitidine
Intervention description: Administered intravenously; Administered intravenously; Administered intravenously; Per I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine given as pretreatment to LY2090314 for stomach pain.
Intervention MeSH terms: Carboplatin; Pemetrexed; Ranitidine; Ranitidine bismuth citrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of
      LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic
      cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B
      will consist of an expanded cohort to confirm the dose provided from Part A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a performance status of less than or equal to 2 on the Eastern Cooperative
             Oncology Group (ECOG) scale

          -  Have a life expectancy of greater than or equal to 12 weeks

          -  Males and females with reproductive potential agree to use medically approved
             contraceptive precautions during the trial and for 3 months following the last dose of
             study drug

          -  Have histological or cytological evidence of a diagnosis of cancer that is advanced
             and/or metastatic disease for which no proven effective therapy exists

          -  Have the presence of measurable or nonmeasurable disease as defined by the Response
             Evaluation Criteria in Solid Tumors (RECIST)

          -  Have adequate hematologic, hepatic, and renal function

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at
             least 30 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and
             recovered from the acute effects of therapy.

        Exclusion Criteria:

          -  Have received treatment within 30 days of the initial dose of study drug with a drug
             that has not received regulatory approval for any indication

          -  Have serious preexisting medical conditions (left to discretion of investigator)

          -  Have one of the following conduction abnormalities: Corrected time between start of Q
             wave and end of T wave (QTc) prolongation >450 millisecond (msec) on screening
             electrocardiogram (ECG), previous history of QTc prolongation with another medication
             that required discontinuation, congenital long-QT-syndrome, or left bundle branch
             block (LBBB)

          -  Are taking any concomitant medication that may cause QTc prolongation, or induce
             Torsades de Pointes

          -  Have systolic blood pressure greater than or equal to 140 millimeters of Mercury (mm
             Hg), and diastolic blood pressure greater than or equal to 90 mm Hg that is not
             controlled by medical therapy

          -  Have serious cardiac condition, such as myocardial infarction within 6 months, angina,
             or heart disease, as defined by the New York Heart Association Class II or higher;
             have history of arrhythmia that is symptomatic or requires treatment

          -  Have chronic atrial fibrillation and/or bradycardia

          -  Have uncorrected electrolyte disorders including potassium <3.4 molar equivalent per
             liter (mEq/L) (<3.4 millimole per liter [mmol/l]), calcium <8.4 milligram per
             deciliter (mg/dL) (2.1 mmol/L), or magnesium <1.2 mg/dL (<0.62 mmol/L)

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not
             required)

          -  Have a hematologic malignancy

          -  Females who are pregnant or lactating