Trial · NCT01987362
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with DLTs | Day 1 up to Day 28 (or Day 21) | |
| Primary | MTD of RO6870810 | Day 1 up to Day 28 (or Day 21) | |
| Primary | Percentage of Participants with Adverse Events | Baseline up to approximately 47 months | |
| Secondary | Area Under the Concentration Versus Time Curve from Time 0 (Pre-dose) to Time 24 Hours (AUC0-24) of RO6870810 | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 24 and 28 hours post-injection on Day 1 Cycle 1; Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, and 4 hours post-injection on Day 15 Cycle 1; random samples on Days 8, 22 of Cycle 1 and on Day 1 of Cycle 2 and every cycle thereafter up to treatment completion (up to 47 months), end of treatment visit/early termination (up to 47 months) (cycle length = 21 or 28 days) |
| Secondary | Maximum Plasma Concentration (Cmax) of RO6870810 | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 24 and 28 hours post-injection on Day 1 Cycle 1; Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, and 4 hours post-injection on Day 15 Cycle 1; random samples on Days 8, 22 of Cycle 1 and on Day 1 of Cycle 2 and every cycle thereafter up to treatment completion (up to 47 months), end of treatment visit/early termination (up to 47 months) (cycle length = 21 or 28 days) |
| Secondary | Time to Reach Cmax (Tmax) of RO6870810 | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 24 and 28 hours post-injection on Day 1 Cycle 1; Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, and 4 hours post-injection on Day 15 Cycle 1; random samples on Days 8, 22 of Cycle 1 and on Day 1 of Cycle 2 and every cycle thereafter up to treatment completion (up to 47 months), end of treatment visit/early termination (up to 47 months) (cycle length = 21 or 28 days) |
| Secondary | Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 as Determined by the Investigator | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length=21 or 28 days) |
| Secondary | Median Time Taken for the First Response Based on RECIST v 1.1 as Determined by the Investigator | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days) |
| Secondary | Median Time Taken for the Best Overall Response Based on RECIST v 1.1 as Determined by the Investigator | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days) |
| Secondary | Progression Free Survival Based on RECIST v 1.1 as Determined by the Investigator | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days) |
| Secondary | Duration of Response Based on RECIST v 1.1 as Determined by the Investigator | Baseline up to 47 months (detailed timeframe is provided in the outcome description) | Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days) |
| Secondary | Overall Survival | Screening up to death due to any cause (up to approximately 47 months) |
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/NCT01987362/registered