Trial · NCT02639546
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months) | Dose-Limiting Toxicities (DLTs) were defined as cobimetinib-related adverse events occurring within the first 28 days of each administration of cobimetinib. |
| Primary | Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. |
| Primary | Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Cobimetinib | Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length=28 days) | A prior dose level was defined as an MTD/MAD if at a certain dose level, there were greater than or equal to (\>=) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs). |
| Primary | Percentage of Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) as Determined by the Investigator Using Modified International Neuroblastoma Response Criteria (mINRC) for Participants With Neuroblastoma (Phase I) | Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment was performed using mINRC for Participants with Neuroblastoma. |
| Primary | Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RANO Criteria for Participants With High-Grade Glioma (HGG) (Phase I) and RECIST v1.1 for Participants With Low-Grade Glioma (LGG) (Phase I and II) | Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment was performed using Response Assessment in Neuro-Oncology (RANO) criteria for participants with HGG and Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) for participants with LGG. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here. |
| Primary | Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 Criteria for Participants With All Other Tumours (Phase I) | Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment was performed using RECIST v1.1 for Participants with All Other Tumours. |
| Primary | Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II) | Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment will be performed using RANO criteria for LGG. |
| Primary | Progression-Free Survival (PFS) as Determined by the Investigator Using mINRC for Participants With Neuroblastoma (Phase I) | From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment was performed using mINRC for Participants with Neuroblastoma. |
| Primary | PFS as Determined by the Investigator Using RANO Criteria for Participants With HGG (Phase I) and RECIST v1.1 for Partcipants With LGG (Phase I and II) | From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment was performed using RANO for participants with HGG and RECIST v1.1 for participants with LGG. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here. |
| Primary | PFS as Determined by the Investigator Using RECIST v1.1 Criteria for Participants With All Other Tumours (Phase I) | From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment was performed using RECIST v1.1 for Participants with All Other Tumours. |
| Primary | PFS as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II) | From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment was performed using RANO criteria for Participants with LGG. |
| Secondary | Recommended Phase II Dose (RP2D) of Cobimetinib | Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length=28 days) | A prior dose level was defined as an RP2D if at a certain dose level, there were greater than or equal to (≥) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs). |
| Secondary | Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 for Participants With LGG (Phase I and II) | From first occurrence of objective response to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment was performed using RECIST v1.1 criteria for participants with LGG. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here. |
| Secondary | DOR as Determined by the Investigator RANO Criteria for Participants With LGG (Phase II) | From first occurrence of objective response to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months) | Tumor assessment was performed using RANO criteria for Participants with LGG. |
| Secondary | Overall Survival (OS) for Participants With Neuroblastoma (Phase I) | Baseline until death due to any cause (up to 5 years, 2 months) | OS was defined as the time from initiation of study drug to death from any cause. |
| Secondary | OS for Participants With High-Grade Glioma (HGG) (Phase I) and Low-Grade Glioma (LGG) (Phase I and II) | Baseline until death due to any cause (up to 5 years, 2 months) | OS was defined as the time from initiation of study drug to death from any cause. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here. |
| Secondary | OS for Participants With All Other Tumours (Phase I) | Baseline until death due to any cause (up to 5 years, 2 months) | OS was defined as the time from initiation of study drug to death from any cause. |
| Secondary | Maximum Plasma Concentration Observed (Cmax) of Cobimetinib | Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (predose=within 4 hours prior to dose; cycle length=28 days) | Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of Cmax. |
| Secondary | Time to Cmax (Tmax) of Cobimetinib | Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (pre-dose=within 4 hours prior to dose; cycle length=28 days) | Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of Tmax. |
| Secondary | Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of Cobimetinib | Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (pre-dose=within 4 hours prior to dose; cycle length=28 days) | Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of AUC0-24. |
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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