Trial · NCT02296476
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) at 6 Months | Month 6 | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study magnetic resonance imaging (MRI). Since no participants reached the 6-month time point in the study, PFS at 6 months could not be calculated. | ||
| SECONDARY | Objective Response Rate (ORR) | Up to 6 Months | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Up to 6 Months | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since no participants experienced a CR or PR, DOR could not be calculated. | ||
| SECONDARY | Overall Survival (OS) | Up to 6 Months | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since all participants discontinued the study due to disease progression, OS could not be calculated. | ||
| SECONDARY | Progression-free Survival | Up to 6 Months | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One Adverse Event (AE) | Up to 6 Months | All participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One Toxicity Grade 3-5 AE | Up to 6 Months | All participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to 6 Months | All participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | Up to Cycle 1 (Up to 28 days) | All participants who received at least 21 days of the planned dose of study drug during the first 28-day cycle or experienced a DLT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Observed Maximum Concentration (Cmax) of MK-8628 | Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours postdose | All participants who received MK-8628 and had blood samples drawn for PK analyses. | μg/Liter | MEAN |
| SECONDARY | Time to Maximum Concentration (Tmax) of MK-8628 | Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours postdose | All participants who received MK-8628 and had blood samples drawn for PK analyses. | hours | MEAN |
| SECONDARY | Apparent Terminal Half-Life (t1/2) of MK-8628 | Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours | All participants who received MK-8628 and had blood samples drawn for PK analyses. | hours | MEAN |
| SECONDARY | Apparent Total Body Clearance (Cl/F) of MK-8628 | Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours | All participants who received MK-8628 and had blood samples drawn for PK analyses. | Liters/hour | MEAN |
| SECONDARY | Apparent Volume of Distribution During the Terminal Phase (Vz/F) of MK-8628 | Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours | All participants who received MK-8628 and had blood samples drawn for PK analyses. | Liters | MEAN |
| SECONDARY | Observed Minimum Concentration (Cmin) of MK-8628 | Predose on Days 29 and 57 | All participants who received MK-8628 and had predose blood samples drawn on Days 29 and 57 for steady state MK-8628 concentration. Participants in the 160 mg dose group were not analyzed for Cmin because they discontinued before Day 29. | μg/Liter | MEAN |
| SECONDARY | Area Under the Concentration-time Curve of MK-8628 From Time 0 to Infinity (AUC 0-∞) | Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours | All participants who received MK-8628 and had blood samples drawn for PK analyses. | μg•hours/Liter | 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/NCT02296476/outcomes