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A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer

Phase 1
18 Years
Not Enrolling
Metastases, Neoplasm

Thank you

Trial Information

A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer

JWAA will consist of the following treatment phases parts:

Part A - Dose escalation phase using a once-daily dosing schedule. Part B - Dose escalation
phase using a twice-daily dosing schedule. Part C - Dose expansion phase using the maximum
tolerated dose from either Part A or Part B.

Inclusion Criteria:

- Have histological or cytological evidence of a diagnosis of cancer that is advanced
and/or metastatic (including Non-Hodgkin's Lymphoma). The patient must be, in the
judgment of the investigator, an appropriate candidate for experimental therapy after
available standard therapies have failed to provide clinical benefit for their

- Have the presence of measurable or nonmeasurable disease as defined by the Response
Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for
Malignant Lymphoma.

Parts A and B: have measurable or nonmeasurable disease. Part C: have measurable 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 8 g/dL. Transfusions are not allowed to reach 8 g/dL prior to

- Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN),
alanine aminotransaminase (ALT), and aspartate aminotransaminase (AST) less than
or equal to 2.5 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 or calculated
creatinine clearance greater than 45 ml/mn.

- 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: at least 28 days for myelosuppressive agents or 14 days for
nonmyelosuppressive agents. At the discretion of the investigator,
hormone-refractory prostate cancer patients who are stable on gonadotropin-releasing
hormone (GnRH) agonist therapy may have that treatment continued while they are
enrolled in this study.

Exclusion Criteria:

- Have received treatment within 28 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 (left to the discretion of the

- Have symptomatic central nervous system (CNS) malignancy 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 current acute or chronic leukemia.

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

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

- Have QTc interval of >470 msec on screening electrocardiogram(ECG).

- Treatment with a strong CYP3A4 substrate with narrow therapeutic range, strong
inhibitor, or inducer.

- Have history of pituitary adenoma.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose for Phase 2 Studies

Outcome Time Frame:

Baseline to study completion

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Spain: Agencia EspaƱola de Medicamentos y Productos Sanitarios

Study ID:




Start Date:

March 2010

Completion Date:

July 2012

Related Keywords:

  • Metastases, Neoplasm
  • Advanced Cancer
  • Metastatic Cancer
  • Solid Tumors
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary