A Study of LY2603618 in Combination With Gemcitabine in Participants With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: LY2603618; Gemcitabine
Intervention description: Administered intravenously; Administered intravenously
Intervention MeSH terms: Gemcitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of LY2603618
      in combination with the standard dose of gemcitabine up to the global recommended dose of
      LY2603618 in Japanese participants with solid advanced or metastatic tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological or imaging evidence of a diagnosis of cancer that is
             advanced and/or metastatic disease

          -  Participant who is planned to have gemcitabine therapy at the proposed doses because
             he/she was not able to benefit from standard therapy and/or therapies known to provide
             clinical benefit or there is no standard therapy for the advanced and/or metastatic
             disease globally

          -  Have given written informed consent prior to any study-specific procedures

          -  Have adequate hematologic, hepatic and renal function

          -  Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG)
             scale

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             cancer-related hormonal therapy, or other investigational therapy for at least 30 days
             (42 days for mitomycin C or nitrosoureas) prior to study enrollment and recovered from
             the acute effects of therapy

          -  Prior radiation therapy for treatment of cancer is allowed to less than 25% of the
             bone marrow, and participants must have recovered from the acute toxic effects of
             their treatment prior to study enrollment. Prior radiation to the whole pelvis is not
             allowed. Prior radiotherapy must be completed at least 30 days prior to study
             enrollment

          -  Males and females with reproductive potential must agree to use medically approved
             contraceptive precautions during the study and for 3 months after the last infusion of
             study drug

          -  Females with child bearing potential (not surgically sterilized and between menarche
             and 1 year post menopause) must have had a negative urine pregnancy test less than 7
             days prior to the enrollment

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

          -  Have an estimated life expectancy of at least 12 weeks

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             study involving an off-label use of an investigational drug or device (other than the
             study drug used in this study), or concurrently enrolled in any other type of medical
             research judged not to be scientifically or medically compatible with this study

          -  Have serious preexisting medical conditions or serious concomitant systemic disorders
             that would compromise the safety of the participant or his/her ability to complete the
             study

          -  Have interstitial pneumonitis or pulmonary fibrosis, or previous history of them

          -  Have symptomatic central nervous system malignancy or metastasis

          -  Have current active infection

          -  Females who are pregnant or lactating

          -  Have known positive test results in human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBSAg), or hepatitis C antibodies (HCAb)

          -  Participants with acute or chronic leukemia or with any other disease likely to have a
             significant bone marrow infiltration

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY2603618 or any other checkpoint kinase (Chk1) inhibitor

          -  Have known allergy to gemcitabine or LY2603618 or any ingredient of gemcitabine or
             LY2603618 (like Captisol®)

          -  Have an abnormal electrocardiogram (ECG) result that would put the participant at
             unnecessary risk in the opinion of the investigator