Trial · NCT02419417
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Adverse Events | From first dose to 30 days following last dose (up to approximately 29 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Hepatic Test Values | From first dose to 30 days following last dose (up to approximately 29 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response (BOR) | From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months) | All treated participants | Percent of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks) | All participants who achieved a Complete Response (CR) or Partial Response (PR) | Weeks | MEAN |
| SECONDARY | Progression Free Survival (PFS) | From first dose to date of first objectively documented disease progression or death (up to approximately 28 months) | All treated participants. | Weeks | MEDIAN |
| SECONDARY | Progression Free Survival Rate (PFSR) | From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose | All treated participants. | Percent of participants | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | Hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | hr | MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Apparent Total Body Clearance (CLT/F) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | mL/min | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration | From drug administration in Cycle 1 Day 1 to 168 hours post drug administration | All treated participants with available measurements | Liters | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort | Hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration | From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C) | All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort | ng/mL | GEOMETRIC_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.
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GET https://conductscience.org/api/trials/v1/NCT02419417/outcomes