Clinical trial NCT02154646: A Study of LY2157299 in Participants With Pancreatic Cancer That is Advanced or Has Spread to Another Part of the Body
Official title: A Phase 1b Study of LY2157299 in Combination With Gemcitabine in Patients With Advanced or Metastatic Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
  * 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 previous or concurrent malignancy except for basal or squamous cell skin cancer (non-melanoma) and/or preinvasive carcinoma of the cervix, mucosal gastrointestinal or uterine carcinoma, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to enrollment.
* Have endocrine pancreatic tumors or ampullary cancer.
* Have current hematological malignancies.
* Have previously completed or withdrawn from this study or any other study investigating LY2157299.
* Have known allergies to LY2157299 or gemcitabine or any ingredient of LY2157299 or gemcitabine formulations.
* Are assessed as inadequate for the study by the investigator.

Primary outcomes:
measure: Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT)
timeFrame: Cycle 1 (28 days)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2157299
timeFrame: 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)
measure: PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2157299
timeFrame: 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)
measure: PK: Cmax of Gemcitabine
timeFrame: Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8
measure: PK: AUC of Gemcitabine
timeFrame: Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8
measure: Percentage of Participants with a Tumor Response
timeFrame: Baseline to study completion (estimated as 5 months)
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: