A Safety Study in Participants With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: Gemcitabine; Docetaxel; Temozolomide; Cisplatin; Erlotinib; LY573636
Intervention description: 1000 mg/m2 administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.; 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.; 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.; 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.; 150 mg administered orally days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.; Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Intervention MeSH terms: Gemcitabine; Docetaxel; Temozolomide; Erlotinib Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced solid tumors; Unresectable; Metastatic; Limited treatment options; Measurable or nonmeasurable disease

Summary:

      The purpose of this study is to determine a safe dose of LY573636 (tasisulam) when used in 5
      separate combinations with an approved cancer medication for treating participants with
      advanced cancer. Data from this study will be reviewed for any side effects or anti-tumor
      activity that may be associated with the LY573636 combination treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have histologically confirmed solid malignancy or lymphoma that is
             unresectable and/or metastatic for which monotherapy with gemcitabine HCl, docetaxel,
             temozolomide, cisplatin, or erlotinib would otherwise be appropriate

          -  Must have tumor progression after receiving standard/approved chemotherapy or limited
             treatment options

          -  Must have measurable or nonmeasurable disease

          -  Have given written informed consent prior to any study-specific procedures

          -  Must have adequate hepatic, hematologic and renal function

          -  Must have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy or other investigational therapy for at
             least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and
             recovered from the acute effects of therapy. Endocrine therapies for the treatment of
             prostate cancer may be continued, at the discretion of the investigator. Whole brain
             radiation must have been completed 90 days before starting study therapy. Participants
             without evidence of brain metastases who have received prophylactic whole brain
             irradiation as part of standard of care for small cell lung cancer may be included in
             the study with a shorter washout period pending approval by the Lilly physician.

          -  Males and females with reproductive potential must agree to use medically approved
             contraceptive precautions during the trial and for 6 months following the last dose of
             study drug.

          -  Females with child-bearing potential must have had a negative serum pregnancy test
             within 7 days prior to the first dose of study drug.

          -  Must have a serum albumin level greater than or equal to 3.0 g/dL (30 g/L).

          -  Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group
             (ECOG) scale

        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 that in the opinion of the investigator
             would preclude participation in the study

          -  Participants with active central nervous system or brain metastasis at the time of
             study entry. Participants with signs or symptoms of neurological compromise should
             have appropriate radiographic imaging performed before study entry to rule out brain
             metastasis. Participants with stable CNS metastasis not requiring steroids may be
             eligible.

          -  Have a current hematologic malignancy (other than lymphoma)

          -  Participants with serious concomitant disorders, including active bacterial, fungal,
             or viral infection, incompatible with the study)

          -  Participants actively receiving warfarin (Coumadin®) therapy

          -  Participants who have previously completed or withdrawn from any study investigating
             LY573636

          -  Participants with a known hypersensitivity to one of the combination drugs cannot be
             enrolled to the treatment arm which includes that chemotherapeutic combination

          -  Females who are pregnant or breast feeding

          -  Have known positive test results of HIV, hepatitis B, or hepatitis C

          -  Participants receiving amiodarone, quinidine, propofol, or clozapine.

          -  Participants receiving treatment with strong or moderate inhibitors of CYP2C19,
             including proton-pump inhibitors (PPIs). Esomeprazole or pantoprazole are allowed if
             not administered 72 hours before or after LY573636 administration.