©2022 Stanford Medicine
A Study in Advanced Cancer
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.
A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer
- 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
- 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
School of Medicine
300 Pasteur Drive
Stanford, CA 94305