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Phase 1 Dose-Escalation Study of LY2157299 Monotherapy in Patients With Solid Tumors

Phase 1
20 Years
Open (Enrolling)
Neoplasms, Neoplasm Metastasis

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Trial Information

Phase 1 Dose-Escalation Study of LY2157299 Monotherapy in Patients With Solid Tumors

Inclusion Criteria:

- Have histological or cytological evidence of a diagnosis of cancer that is advanced
and/or metastatic. The participants 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 disease.

- Have the presence of measurable or nonmeasurable disease as defined by the Response
Evaluation Criteria in Solid Tumors.

- Have a performance status of higher than or equal to 1 on the Eastern Cooperative
Oncology Group scale.

- Have adequate hematologic, hepatic and renal function.

- Have discontinued treatments for cancer excluding palliative treatments and recovered
from the acute effects of therapy.

- Have discontinued treatment at least 28 days prior to the enrollment for an
experimental agent that has not received regulatory approval for any indication.

- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures.

- Able to swallow tablets.

- Have an estimated life expectancy, in the judgment of the investigator, that will
permit the participant to complete greater than or equal to 2 cycles of treatment.

- Males and females with reproductive potential: Must agree to use medically approved
contraceptive precautions during the study and for 4 months following the last dose
of study drug.

- Females with child bearing potential: Have had a negative urine/serum pregnancy test
greater than or equal to 7 days before the first dose of study drug and must also not
be breastfeeding. If female who stops breastfeeding enters the study, the female
must stop breastfeeding from the day of the first study drug administration until at
least 30 days after the last administration.

Exclusion Criteria:

- Have moderate or severe cardiac disease:

- Have the presence of cardiac disease, including a myocardial infarction within 6
months prior to study entry, angina pectoris, New York Heart Association Class
III/IV congestive heart failure, or uncontrolled severe hypertension.

- Have documented major electrocardiogram abnormalities at the investigator's

- Have major abnormalities documented by echocardiography with Doppler.
Clinically non-significant abnormalities are excluded from this criterion.

- Have persistently elevated brain natriuretic peptide or elevated Troponin I at
screening local laboratory tests.

- Have predisposing conditions that are consistent with development of aneurysms
of the ascending aorta or aortic stress.

- Have a history of cardiac or aortic surgery.

- Have current hematological malignancies.

- Have central nervous system metastases.

- Have serious preexisting medical conditions as follows;

- Presence or history of interstitial pneumonitis

- Uncontrollable severe diabetes

- Presence of serious active infection or uncontrollable chronic infection

- Presence of liver cirrhosis with Child-Pugh Stage of B or C

- Other serious conditions judged by the investigator

- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B
surface antigen, or hepatitis C antibodies (HC Ab). Testing is not required unless
circumstances warrant confirmation.

- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants with Dose-Limiting Toxicities

Outcome Time Frame:

Day 1 through Day 28 of Cycle 1

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


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

November 2012

Completion Date:

January 2014

Related Keywords:

  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasm Metastasis