Study of LY2157299 in Japanese Participants With Cancer

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722825
• Other study ID #: 14854
• Secondary ID: H9H-JE-JBAN
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2012
• Last updated: June 30, 2014
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and side effects of LY2157299 in Japanese participants with advanced cancer or cancer that has spread to other parts of the body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 discretion.

• 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 study.

Study Design

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• LY2157299
Administered orally.

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559 ) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose-Limiting Toxicities		Day 1 through Day 28 of Cycle 1	Yes
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299		Days 1, 3, 6 and 14 of Cycle 1 and Days 1 and 14 of Cycle 2	No
Secondary	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY2157299		Predose up to 6 hours postdose on Days 1 and 14 of Cycles 1 and 2	No
Secondary	Number of Participants with a Tumor Response		Baseline to study completion estimated at 16 weeks	No