Trial · NCT01287520
A Study of LY2090314 in Patients With Advanced or Metastatic Cancer
NCT01287520, Phase 1, Completed, Eli Lilly and Company; results first posted 2019-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of LY2090314 in Patients With Advanced or Metastatic Cancer. Trials, record NCT01287520. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01287520
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY2090314 in Patients With Advanced or Metastatic Cancer
- NCT number
- NCT01287520
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 41 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Advanced Cancer
- Interventions
- LY2090314, pemetrexed, Carboplatin, ranitidine
- First posted
- 2011-02-01
- Last updated
- 2019-02-25
- Results first posted
- 2019-02-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD]) | Baseline up to Day 28 (Cycle 1) | Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of \>5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval. |
| Secondary | Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314 | Cycle 1 Day 1 of a 28 day cycle | AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone. |
| Secondary | PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb) | Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle | AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb. |
| Secondary | PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 | Cycle 1 Day 1 of a 28-day cycle | |
| Secondary | PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb) | Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle | |
| Secondary | Number of Participants With Best Overall Tumor Response | Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days) | Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. |
| Secondary | Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem) | Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle | AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy). |
| Secondary | PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem) | Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle | Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy). |
| Secondary | PK Parameter: AUC0-∞ of Free Carboplatin (Carb) | Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle | AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy). |
| Secondary | PK Parameter: Cmax of Free Carboplatin | Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle | Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD]) | Baseline up to Day 28 (Cycle 1) | Safety population: all participants who have received at least 1 dose of the study drug. | milligrams (mg) | NUMBER |
| SECONDARY | Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314 | Cycle 1 Day 1 of a 28 day cycle | All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the wrong dose of LY2090314. | nanograms*hour per milliliter | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb) | Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle | All participants who received at least 1 dose LY2090314 coadministered with Pem and Carb and had enough samples to allow estimation of AUC0-∞ parameters excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314. | nanograms*hour per milliliter | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 | Cycle 1 Day 1 of a 28-day cycle | All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314. | nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb) | Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle | All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314. | nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Best Overall Tumor Response | Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days) | Analysis population: all participants who received at least 1 dose of study drug and had tumor response assessment. | participants | NUMBER |
| SECONDARY | Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem) | Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle | All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable AUC0-∞ Pem data. | hours*nanograms/milliliter/ milligram | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem) | Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle | All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable Cmax Pem data. | nanogram per milliliter per milligram | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter: AUC0-∞ of Free Carboplatin (Carb) | Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle | All participants who were treated with Pem and Carb (doublet therapy) or Pem, Carb and LY2090314 (triplet therapy) and who had evaluable Carb AUC0-∞ data. | hours*nanograms per milliliter per mg | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter: Cmax of Free Carboplatin | Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle | All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable Carb Cmax data. | nanograms/milliliter/milligram | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD]) | LY2090314/Pemetrexed/Carboplatin | 40 | milligrams (mg) | ||
| Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314 | LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2) | 216 | Geometric Coefficient of Variation 26.3 | nanograms*hour per milliliter | |
| Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314 | LY 20/Carb 6/Pem 500 (Cohort 3) | 427 | Geometric Coefficient of Variation 21.8 | nanograms*hour per milliliter | |
| Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314 | LY 40/Carb 6/Pem 500 (Cohorts 4 and 9) | 976 | Geometric Coefficient of Variation 42.6 | nanograms*hour per milliliter | |
| Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314 | LY 80/Carb 6/Pem 500 (Cohorts 5 and 7) | 1870 | Geometric Coefficient of Variation 76.7 | nanograms*hour per milliliter | |
| Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314 | LY 120/Carb 6/Pem 500 (Cohort 6) | 3310 | Geometric Coefficient of Variation 18.7 | nanograms*hour per milliliter | |
| Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314 | LY 60/Carb 6/Pem 500 + R50 (Cohort 8) | 1600 | Geometric Coefficient of Variation 47.3 | nanograms*hour per milliliter | |
| PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb) | LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2) | 192 | Geometric Coefficient of Variation 48.2 | nanograms*hour per milliliter | |
| PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb) | LY 20/Carb 6/Pem 500 (Cohort 3) | 404 | Geometric Coefficient of Variation 33.2 | nanograms*hour per milliliter | |
| PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb) | LY 40/Carb 6/Pem 500 (Cohorts 4 and 9) | 938 | Geometric Coefficient of Variation 33.5 | nanograms*hour per milliliter |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY 10/Carb 5/Pem 500 (Cohort 1) | 3 | |
| Overall Study | STARTED | LY 10/Carb 6/Pem 500 (Cohort 2) | 7 | |
| Overall Study | STARTED | LY 20/Carb 6/Pem 500 (Cohort 3) | 5 | |
| Overall Study | STARTED | LY 40/Carb 6/Pem 500 (Cohort 4) | 7 | |
| Overall Study | STARTED | LY 80/Carb 6/Pem 500 (Cohort 5) | 3 | |
| Overall Study | STARTED | LY 120/Carb 6/Pem 500 -(Cohort 6) | 4 | |
| Overall Study | STARTED | LY 80/Carb 6/Pem 500 + R50 (Cohort 7) | 2 | |
| Overall Study | STARTED | LY 60/Carb 6/Pem 500 + R50 (Cohort 8) | 5 | |
| Overall Study | STARTED | LY 40/Carb 6/Pem 500 + R50 (Cohort 9) | 5 | |
| Overall Study | COMPLETED | LY 10/Carb 5/Pem 500 (Cohort 1) | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events1,386
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 | Anaemia | Blood and lymphatic system disorders | LY 10/Carb 5/Pem 500 (Cohort 1) | 2 | 3 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | LY 10/Carb 6/Pem 500 (Cohort 2) | 6 | 7 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | LY 20/Carb 6/Pem 500 (Cohort 3) | 5 | 5 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | LY 40/Carb 6/Pem 500 (Cohort 4) | 5 | 7 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | LY 80/Carb 6/Pem 500 (Cohort 5) | 2 | 3 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | LY 120/Carb 6/Pem 500 (Cohort 6) | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | LY 80/Carb 6/Pem 500 + R50 (Cohort 7) | 1 | 2 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | LY 60/Carb 6/Pem 500 + R50 (Cohort 8) | 4 | 5 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | LY 40/Carb 6/Pem 500 + R50 (Cohort 9) | 3 | 5 | 5 |
| other | Leukocytosis | Blood and lymphatic system disorders | LY 10/Carb 5/Pem 500 (Cohort 1) | 0 | 3 | 0 |
1 to 10 of 1,386Source ClinicalTrials.gov
See all 1,386 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY 10/Carb 5/Pem 500 (Cohort 1) | ||
| Total, all-cause mortality | LY 10/Carb 6/Pem 500 (Cohort 2) | ||
| Total, all-cause mortality | LY 20/Carb 6/Pem 500 (Cohort 3) | ||
| Total, all-cause mortality | LY 40/Carb 6/Pem 500 (Cohort 4) | ||
| Total, all-cause mortality | LY 80/Carb 6/Pem 500 (Cohort 5) | ||
| Total, all-cause mortality | LY 120/Carb 6/Pem 500 (Cohort 6) | ||
| Total, all-cause mortality | LY 80/Carb 6/Pem 500 + R50 (Cohort 7) | ||
| Total, all-cause mortality | LY 60/Carb 6/Pem 500 + R50 (Cohort 8) | ||
| Total, all-cause mortality | LY 40/Carb 6/Pem 500 + R50 (Cohort 9) | ||
| Total, other adverse events | LY 10/Carb 5/Pem 500 (Cohort 1) | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26403509 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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