Trial · NCT01632306
A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer
NCT01632306, Phase 1, Phase 2, Terminated, Eli Lilly and Company; results first posted 2018-11-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer. Trials, record NCT01632306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01632306
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer
- NCT number
- NCT01632306
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Pancreatic Cancer
- Interventions
- LY2090314, FOLFOX, Gemcitabine, Nab-paclitaxel
- First posted
- 2012-07-02
- Last updated
- 2019-01-15
- Results first posted
- 2018-11-19
- Limitations and caveats
- Study was terminated due to slow enrollment. No participants were enrolled in arm LY2090314 + Gemcitabine + Nab-paclitaxel due to inability to enroll participants.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation | Baseline, 4 Hours Post-Treatment on Day 0 | 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. |
| Secondary | Overall Survival (OS) | Baseline to Date of Death Due to any Cause Up to 21 Months | |
| Secondary | Percentage of Participants Who Survived at 6 Months | Baseline to Date of Death to any cause Up to 6 Months | |
| Secondary | Progression Free Survival (PFS) | Baseline to Disease Progression Up to 18 Months | PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first. |
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | Baseline Up to 6 Months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation | Baseline, 4 Hours Post-Treatment on Day 0 | Zero participants analyzed. GSK3β phosphorylation levels were not determined, and the primary endpoint was not examined as there wasn't viable tumor tissue for analysis. | ||
| SECONDARY | Overall Survival (OS) | Baseline to Date of Death Due to any Cause Up to 21 Months | All the participants that received at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Survived at 6 Months | Baseline to Date of Death to any cause Up to 6 Months | All participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Baseline to Disease Progression Up to 18 Months | All participants who received at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | Baseline Up to 6 Months | All participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | LY2090314 + Gemcitabine | 1.8 | 95% Confidence Interval 1.3 to 1.9 | Months | |
| Overall Survival (OS) | LY2090314 + FOLFOX | 7.7 | 95% Confidence Interval 2.9 to 21.2 | Months | |
| Percentage of Participants Who Survived at 6 Months | LY2090314 + Gemcitabine | 0 | 90% Confidence Interval 0 to 0 | Percentage of participants | |
| Percentage of Participants Who Survived at 6 Months | LY2090314 + FOLFOX | 50.0 | 90% Confidence Interval 26.9 to 92.9 | Percentage of participants | |
| Progression Free Survival (PFS) | LY2090314 + Gemcitabine | 1.8 | 95% Confidence Interval 1.3 to 1.9 | Months | |
| Progression Free Survival (PFS) | LY2090314 + FOLFOX | 3.4 | 95% Confidence Interval 2.3 to 17.5 | Months | |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | LY2090314 + Gemcitabine | 0 | 95% Confidence Interval NA to NA | Percentage of Participants | |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | LY2090314 + FOLFOX | 10.0 | 95% Confidence Interval 0.3 to 44.5 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY2090314 + Gemcitabine | 3 | |
| Overall Study | STARTED | LY2090314 + FOLFOX | 10 | |
| Overall Study | STARTED | LY2090314 + Gemcitabine + Nab-paclitaxel | 0 | |
| Overall Study | Received at Least One Dose of Study Drug | LY2090314 + Gemcitabine | 3 | |
| Overall Study | Received at Least One Dose of Study Drug | LY2090314 + FOLFOX | 10 | |
| Overall Study | Received at Least One Dose of Study Drug | LY2090314 + Gemcitabine + Nab-paclitaxel | 0 | |
| Overall Study | COMPLETED | LY2090314 + Gemcitabine | 2 | |
| Overall Study | COMPLETED | LY2090314 + FOLFOX | 10 | |
| Overall Study | COMPLETED | LY2090314 + Gemcitabine + Nab-paclitaxel | 0 | |
| Overall Study | NOT COMPLETED | LY2090314 + Gemcitabine | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events174
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | LY2090314 + Gemcitabine | 2 | 3 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | LY2090314 + FOLFOX | 8 | 10 | 25 |
| other | Adrenal insufficiency | Endocrine disorders | LY2090314 + Gemcitabine | 0 | 3 | 0 |
| other | Adrenal insufficiency | Endocrine disorders | LY2090314 + FOLFOX | 1 | 10 | 1 |
| other | Akathisia | Nervous system disorders | LY2090314 + Gemcitabine | 0 | 3 | 0 |
| other | Akathisia | Nervous system disorders | LY2090314 + FOLFOX | 1 | 10 | 7 |
| other | Alanine aminotransferase | Investigations | LY2090314 + Gemcitabine | 1 | 3 | 1 |
| other | Alanine aminotransferase | Investigations | LY2090314 + FOLFOX | 4 | 10 | 11 |
| other | Alkaline phosphatase | Investigations | LY2090314 + Gemcitabine | 0 | 3 | 0 |
| other | Alkaline phosphatase | Investigations | LY2090314 + FOLFOX | 3 | 10 | 7 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2090314 + Gemcitabine | ||
| Total, all-cause mortality | LY2090314 + FOLFOX | ||
| Total, other adverse events | LY2090314 + Gemcitabine | 2 | 3 |
| Total, other adverse events | LY2090314 + FOLFOX | 10 | 10 |
| Total, serious adverse events | LY2090314 + Gemcitabine | 3 | 3 |
| Total, serious adverse events | LY2090314 + FOLFOX | 7 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LY2090314 + Gemcitabine vs LY2090314 + FOLFOX: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01632306
GET https://conductscience.org/api/trials/v1/NCT01632306/events?page=2