Trial · NCT01801358
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle | Cycle 1 (up to 28 days) | Analysis is comprised of the Dose-determining Set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1. | DLTs | NUMBER |
| PRIMARY | Phase II: Progression Free Survival (PFS) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | |||
| SECONDARY | Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group consists of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment. | participants | NUMBER |
| SECONDARY | Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment. | participants | NUMBER |
| SECONDARY | Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR) | Cycle 1 (up to 28 days) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | participants | NUMBER |
| SECONDARY | Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR) | Cycle 1 (up to 28 days) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | ||
| SECONDARY | Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS) | Cycle 1 (up to 28 days) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | weeks | MEDIAN |
| SECONDARY | Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | ||
| SECONDARY | Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | ||
| SECONDARY | Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | ||
| SECONDARY | Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS) | From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit) | Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162. | ||
| SECONDARY | Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1) | Cycle 1 (Day 1) | This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data. | hr*ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1) | Cycle 1 (Day 1) | This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data. | ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1) | Cycle 1 (Day 1) | This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data. | hr | MEDIAN |
| SECONDARY | Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15) | Cycle 1 (Day 15) | This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data. | hr*ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15) | Cycle 1 (Day 15) | This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data. | ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15) | Cycle 1 (Day 15) | This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data. | hr | MEDIAN |
| SECONDARY | Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1) | Cycle 1 (Day 1) | This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data. | hr*ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1) | Cycle 1 (Day 1) | This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data. | ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1) | Cycle 1 (Day 1) | This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data. | hr | MEDIAN |
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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