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Pancreatic NeoplasmsPhase 1NCT02154646

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

A Phase 1 study testing LY2157299 and Gemcitabine in people with Pancreatic Neoplasms, run by Eli Lilly and Company at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
LY2157299 and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesJapan
Study dates
May 2014to Jul 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • 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

  • 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

Other trials in Japan

About this study

Official title: A Phase 1b Study of LY2157299 in Combination With Gemcitabine in Patients With Advanced or Metastatic Unresectable Pancreatic Cancer

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.

Being tested
LY2157299, Gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY2157299Drug

    Administered orally

  • GemcitabineDrug

    Administered IV

Study groups in NCT02154646
Study groupRoleWhat they receive
LY2157299 + GemcitabineExperimental150 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.
Receives: Drug: LY2157299; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Cycle 1 (28 days)

Secondary outcomes (5)

  1. Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2157299

    Measured: 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)

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

    Measured: 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)

  3. PK: Cmax of Gemcitabine

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

  4. PK: AUC of Gemcitabine

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

  5. Percentage of Participants with a Tumor Response

    Measured: Baseline to study completion (estimated as 5 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2014
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02154646
Sponsor's protocol ID
14855
Other IDs
H9H-JE-JBAO
Status last verified
Feb 2016
First submitted
14 May 2014
Last updated
10 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2157299 and Gemcitabine in people with Pancreatic Neoplasms, run by Eli Lilly and Company at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT) (time frame: Cycle 1 (28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02154646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.

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