A Study in Advanced Cancer

Not Recruiting

Trial ID: NCT01226485


The purpose of this study is to find a recommended dose level and schedule of dosing LY2940680 that can safely be taken by participants with advanced cancer. The study will also explore the changes in a cancer marker level in skin, hair follicles, buccal cells, and tumor cells. Finally, the study will help document any antitumor activity this drug may have.

Official Title

A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer

Stanford Investigator(s)

Anne Lynn S. Chang, MD
Anne Lynn S. Chang, MD

Professor of Dermatology

Anthony Oro, MD, PhD
Anthony Oro, MD, PhD

Eugene and Gloria Bauer Professor

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Inclusion Criteria:

   - Have histological or cytological evidence of a diagnosis of cancer that is advanced
   and/or metastatic. The patient must be, in the judgment of the investigator, an
   appropriate candidate for experimental therapy.

   - Have the presence of measurable or nonmeasurable disease

   - Have adequate organ function, including:

      - Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x
      109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater
      than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve
      this hemoglobin level at the discretion of the investigator. Initial treatment
      must not begin until 5 days after the erythrocyte transfusion.

      - Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN),
      ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the
      liver has tumor involvement AST and ALT equaling less than or equal to 5 times
      ULN are acceptable.

      - Renal: Serum creatinine less than or equal to 1.5 times ULN.

   - Have a performance status of less than or equal to 1 on the Eastern Cooperative
   Oncology Group (ECOG) scale

   - Have discontinued previous treatments for cancer and recovered from the acute effects
   of therapy (for example, at least 42 days for mitomycin-C or nitrosoureas, 28 days for
   other chemotherapy and biologics. At the discretion of the investigator, hormone
   refractory prostate cancer patients who are stable on gonadotropin-releasing hormone
   (GnRH) agonist therapy and breast cancer patients who are stable on antiestrogen
   therapy (for example, an aromatase inhibitor) may continue treatment

Exclusion Criteria:

   - Have received treatment within 21 days of the initial dose of study drug with an
   experimental agent for noncancer indications that has not received regulatory approval
   for any indication.

   - Have serious preexisting medical conditions

   - Have symptomatic central nervous system (CNS) malignancy (with the exception of
   medulloblastoma) or metastasis (screening not required). Patients with treated CNS
   metastases are eligible for this study if they are not currently receiving
   corticosteroids and/or anticonvulsants, and their disease is asymptomatic and
   radiographically stable for at least 60 days.

   - Have known current hematologic malignancies or acute or chronic leukemia

   - Have a known active fungal, bacterial, and/or known viral infection including human
   immunodeficiency (HIV) or viral (A, B, or C) hepatitis (screening is not required)

   - Have a second primary malignancy that in the judgment of the investigator and sponsor
   may affect the interpretation of results

   - Have QTc interval of >500 msec on screening electrocardiogram

   - Patients who have previously received treatment with LY2940680


drug: Taladegib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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