A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
Condition: Ovarian Cancer; Non Small Cell Lung Cancer; Prostate Cancer; Colorectal Cancer; Gastric Cancer; Esophageal Cancer; Cancer of Head and Neck
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms
Intervention: LY2523355; pegfilgrastim
Intervention description: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer patients). Additional cycles administered based on patient response assessment.; 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer patients). Additional cycles of LY2523355 administered based on patient response assessment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to estimate the rate of response for patients with ovarian,
      non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who
      are administered LY2523355.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal
             cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal
             junction), or squamous cell cancer of the head and neck

          -  Have measurable disease defined by Response Evaluation Criteria in Solid Tumors
             (RECIST) 1.1 guidelines (except prostate cancer participants)

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

          -  Are willing to follow study procedures for the duration of the study

          -  Are willing to use an approved contraceptive method during treatment and for 3 months
             after discontinuation of study treatment

        Exclusion Criteria:

          -  Have a serious preexisting medical condition that would preclude participation in the
             study

          -  Are pregnant or lactating

          -  Have received treatment within 28 days of first dose of LY2523355 with a drug that has
             not received regulatory approval for any indication

          -  Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases

          -  Have a second active primary malignancy or a history of a second malignancy requiring
             cytotoxic therapy

          -  Have QTc interval greater than 470 millisecond (msec) or intraventricular conduction
             delay (IVCD) with QRS greater than 120 msec on screening electrocardiogram (ECG)

          -  Have active symptomatic fungal, bacterial, and/or known viral infection including
             active human immunodeficiency virus (HIV) or viral (A, B, C) hepatitis

          -  Participants with pneumonia, evidence of obstructive pneumonitis, other respiratory
             infections, or infection from other sources are to be excluded