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Pancreatic CancerPhase 1/2NCT01632306

A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer

A Phase 1/2 study testing LY2090314, FOLFOX and Gemcitabine in people with Pancreatic Cancer, run by Eli Lilly and Company at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
LY2090314, FOLFOX and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesUnited States
Study dates
Mar 2013to Jun 2015
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Metastatic pancreatic cancer with metastases amenable to biopsy
  • Willingness to provide tissue and blood samples for research purposes
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

Who cannot join

  • History of islet cell, acinar cell, or cystadenocarcinomas
  • Prior cytotoxic chemotherapy for metastatic disease, except prior gemcitabine or FOLFIRINOX (5FU + leucovorin + irinotecan + oxaliplatin)
  • Radiation therapy, immunotherapy or biologic therapy <28 days prior to study entry

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mayo Clinic of Jacksonville

    Jacksonville, Florida, 32224

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy

Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.

Being tested
LY2090314, FOLFOX, Gemcitabine, Nab-paclitaxel
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • LY2090314Drug

    LY2090314 administered IV

  • FOLFOXDrug

    Also called FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin)

    FOLFOX administered IV

  • GemcitabineDrug

    Also called Gemzar, LY188011

    Gemcitabine administered IV

  • Nab-paclitaxelDrug

    Nab-paclitaxel administered IV

Study groups in NCT01632306
Study groupRoleWhat they receive
LY2090314 + GemcitabineExperimentalLY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m^2) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.
Receives: Drug: LY2090314; Drug: Gemcitabine
LY2090314 + FOLFOXExperimentalLY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle.
Receives: Drug: LY2090314; Drug: FOLFOX
LY2090314 + Gemcitabine + Nab-paclitaxelExperimentalLY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 mg/m^2 gemcitabine + 125 mg/m^2 nab-paclitaxel given IV on days 1, 8 and 15 in 28-day cycle. New cohort opened per protocol amendment.
Receives: Drug: LY2090314; Drug: Gemcitabine; Drug: Nab-paclitaxel

What is being measured

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

  1. Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation

    Change in the phosphorylation level of glycogen synthase, a glycogen synthase kinase-3 beta (GSK-3beta) inhibitor, from baseline to 4 hours post-treatment on day 0 using tumor tissue and blood specimens.

    Measured: Baseline, 4 Hours Post-Treatment on Day 0

Secondary outcomes (4)

  1. Overall Survival (OS)

    Measured: Baseline to Date of Death Due to any Cause Up to 21 Months

  2. Percentage of Participants Who Survived at 6 Months

    Measured: Baseline to Date of Death to any cause Up to 6 Months

  3. Progression Free Survival (PFS)

    PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first.

    Measured: Baseline to Disease Progression Up to 18 Months

  4. Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.

    A CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.

    Measured: Baseline Up to 6 Months

Timeline

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

  1. First posted2 Jul 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionJun 2015
  4. Study completionJun 2015

Why it stopped: Study has been terminated due to slow enrollment.

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01632306
Sponsor's protocol ID
14453
Other IDs
I2H-MC-JWYD
Status last verified
Jan 2019
First submitted
28 Jun 2012
Last updated
15 Jan 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LY2090314, FOLFOX and Gemcitabine in people with Pancreatic Cancer, run by Eli Lilly and Company at 2 sites in United States.

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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Jan 2019. 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 United States. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation (time frame: Baseline, 4 Hours Post-Treatment on Day 0). 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 NCT01632306.

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 15 Jan 2019.

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