Trial · NCT01025284
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 | Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | Date of enrollment to date of measured progressive disease up to 99.6 weeks | All participants who received at least 1 dose of study drug in Part A. | percentage of participants | NUMBER |
| PRIMARY | Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Date of enrollment to date of measured progressive disease up to 18.1 weeks | All participants who received at least 1 dose of study drug in Part B. | percentage of participants | NUMBER |
| SECONDARY | Part A: Progression-Free Survival | Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks | All participants who received at least 1 dose of study drug in Part A. The numbers of participants censored are 4. | weeks | MEDIAN |
| SECONDARY | Part B: Progression-Free Survival | Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks | All participants who received at least 1 dose of study drug in Part B. The numbers of participants censored are 4. | weeks | MEDIAN |
| SECONDARY | Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Date of enrollment to date of measured progressive disease 99.6 weeks | All participants who received at least 1 dose of study drug in Part A. | percentage of participants | NUMBER |
| SECONDARY | Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | Date of enrollment to date of measured progressive disease up to 18.1 weeks | All participants who received at least 1 dose of study drug in Part B. | percentage of participants | NUMBER |
| SECONDARY | Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307) | Days 1,5 and 9 of Cycle 1 (21-day cycle) | All participants who received 1 dose of study drug on Days 1, 5, and 9 of Cycle 1 and had Cmax samples collected on Days 1, 5, and 9 of Cycle 1 in Part A. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 | Day 3 of Cycle 1 (21-day cycle) | All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had Cmax samples collected on Day 3 of Cycle 1 in Part B. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | Days 1,5 and 9 of Cycle 1 (21-day cycle) | No participants were analyzed due to the very limited pharmacokinetic sampling employed in Part A that did not allow accurate calculation of the AUC(0-∞) on Days 1, 5, and 9 of Cycle 1. | ||
| SECONDARY | Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | Day 3 of Cycle 1 (21-day cycle) | All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had pharmacokinetic samples collected on Day 3 of Cycle 1 in Part B that enabled calculation of the AUC(0-∞). | nanograms*hour/milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI) | Baseline and follow-up up to 104 weeks after the first dose of study drug | All participants who received at least 1 dose of study drug and had total LCSS and ASBI scores at baseline and follow-up in Part B. | units on a scale | MEAN |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01025284/outcomes