A Study of LY2157299 in Participants With Pancreatic Cancer That is Advanced or Has Spread to Another Part of the Body

NCT02154646 | Completed Phase 1 DMC

• 2 other identifiers: 14855H9H-JE-JBAO
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to evaluate the safety and side effects of LY2157299 in combination with gemcitabine in Japanese participants with pancreatic cancer that is advanced or has spread to another part of the body.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT)

  Cycle 1 (28 days)

Secondary Outcomes (5)

• Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2157299

  Cycle 1: Predose on Day 1 through Day 28, Cycle 2 through last cycle: Predose on Day 1 (Cycle = 28 days; treatment estimated to last 4 cycles)

• PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2157299

  Cycle 1: Predose on Day 1 through Day 28, Cycle 2 through last cycle: Predose on Day 1 (Cycle = 28 days; treatment estimated to last 4 cycles)

• PK: Cmax of Gemcitabine

  Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8

• PK: AUC of Gemcitabine

  Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8

• Percentage of Participants with a Tumor Response

  Baseline to study completion (estimated as 5 months)

Study Arms (1)

LY2157299 + Gemcitabine

EXPERIMENTAL

150 mg LY2157299 is administered orally twice daily for 14 days followed by 14 days without study drug (28 day cycle.) Gemcitabine 1000 milligram per square meter will be administered intravenously (IV) on Days 8, 15, and 22 in each cycle (28 day cycle). Participants may continue to receive treatment until discontinuation criteria are met.

Drug: LY2157299; Drug: Gemcitabine

Interventions

LY2157299 DRUG

Administered orally

LY2157299 + Gemcitabine

Gemcitabine DRUG

Administered IV

LY2157299 + Gemcitabine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced or metastatic and not amenable to resection with curative intent. These participants may have received prior chemotherapy, radiotherapy, cancer-related hormone therapy, or other investigational therapy as treatment or chemotherapy.
• Participants with previous radical surgery for pancreatic cancer are eligible after progression is documented.
• Have measurable disease or non-measurable disease, defined according to Response Evaluation Criteria in Solid Tumors (RECIST).
• Have given written informed consent prior to any study-specific procedures.
• Have adequate organ function.
• Have a performance status of less than or equal 1 on the Eastern Cooperative Oncology Group (ECOG).
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
• Prior radiation therapy for treatment of cancer is allowed to less than 25% of the bone marrow, and participants must have recovered from the acute toxic effects of their treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed.
• Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug.

You may not qualify if:

• Are currently enrolled in, or discontinued within the last 30 days of study enrollment, a clinical trial involving an investigational product or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
• Have moderate or severe cardiac disease:
• Myocardial infarction within 6 months prior to study enrollment, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension.
• Documented major electrocardiogram (ECG) abnormalities at the investigator's discretion.
• Major abnormalities documented by echocardiography with Doppler.
• Have significantly elevated brain natriuretic peptide (BNP) or elevated Troponin I at screening local laboratory tests.
• 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 known positive tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus antibodies (HCVAbs).
• Have symptomatic central nervous system (CNS) malignancy or metastasis.
• Are unable to swallow tablets or capsules.
• Are pregnant or breastfeeding.
• Have serious preexisting medical conditions as follows:
• Presence or history of interstitial pneumonitis.
• Uncontrollable severe diabetes.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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.

Chiba, 277 8577, Japan

Location

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, 104-0045, Japan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

LY-2157299; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

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

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: June 3, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: July 1, 2015
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

JP (2)