Trial · NCT01287520
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| SECONDARY | Pharmacodynamic (PD) Changes in Beta-Catenin (β-catenin) | Baseline, Cycle 1 , Day 1 of a 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycles | There was insufficient data from participants who received at least 1 dose of LY2090314 to perform β-catenin modeling, thus zero participants were analyzed. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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