Notch Inhibitor in Advanced Cancer
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: LY900009 - Dose Escalation Phase (Part A); LY900009 - Dose Confirmation Phase (Part B)
Intervention description: 2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.
Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.; 30 mg LY900009 orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.
Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.
Intervention MeSH terms: LY900009
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Cancer; Solid Tumors

Summary:

      The objective of this phase 1 study is to evaluate the safety and tolerability of Notch
      Inhibitor in participants with advanced cancer. This study includes dose escalation and dose
      confirmation components.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participants must be, in the judgment of the investigator, an appropriate
             candidate for experimental therapy after available standard therapies have ceased to
             provide clinical benefit for their disease.

          -  The participants must have histological or cytological evidence of cancer, either a
             solid tumor or a lymphoma, which is advanced and/or metastatic.

          -  Have adequate organ function including:

               -  Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/liter (L), platelets ≥100
                  x 10⁹/L, and hemoglobin ≥8 grams/deciliter (g/dL).

               -  Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN) and alanine
                  aminotransferase (ALT) ≤3.0 times ULN.

               -  Renal: Serum creatinine ≤1.5 times ULN.

          -  Have a performance status less than or equal to 1 for Dose Escalation and less than or
             equal to 2 for Dose Confirmation on the Eastern Cooperative Oncology Group (ECOG)
             scale.

          -  Have discontinued all previous therapies for cancer (including chemotherapy,
             radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for
             myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving
             study drug, and recovered from the acute effects of therapy (treatment-related
             toxicity resolved to baseline) except for residual alopecia.

          -  Males and females with reproductive potential must agree to use medically approved
             contraceptive precautions during the trial and for 3 months following the last dose of
             study drug.

          -  Females with childbearing potential must have a negative serum pregnancy test within 7
             days of the first dose of study drug.

        Exclusion Criteria:

          -  Have received treatment with a drug that has not received regulatory approval for any
             indication within 14 or 21 days of the initial dose of study drug for a
             nonmyelosuppressive or myelosuppressive agent, respectively.

          -  Have serious preexisting medical conditions that, in the judgment of the investigator,
             would preclude participation in this study (for example, inflammatory bowel disease or
             history of major surgical resection involving the stomach or small bowel).

          -  Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or
             diarrhea (acute or chronic).

          -  Females who are pregnant or lactating.

          -  Have Central Nervous System (CNS) malignancy or metastasis.

          -  Have an acute leukemia.

          -  Have active bacterial, fungal and/or known viral infection.