Trial · NCT02639546
Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors
NCT02639546, Phase 1, Phase 2, Completed, Hoffmann-La Roche; results first posted 2022-03-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors. Trials, record NCT02639546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02639546
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors
- NCT number
- NCT02639546
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Solid Tumors
- Interventions
- Cobimetinib
- First posted
- 2015-12-24
- Last updated
- 2022-09-16
- Other registries' IDs
- eudract:2014-004685-25
- Results first posted
- 2022-03-31
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. | mg/kg | NUMBER |
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type. | Percentage of Participants | NUMBER |
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type. | Percentage of Participants | NUMBER |
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type. | Percentage of Participants | NUMBER |
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. For phase II, only one tumor type cohort was opened (LGG). | Percentage of Participants | NUMBER |
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type. | Months | MEDIAN |
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type. | Months | MEDIAN |
| 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) | The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type. | Months | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 0 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 0 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Phase I (Tablet) Cobimetinib (1 mg/kg) | 33.3 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 16.7 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 0 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Phase I (Suspension) Cobimetinib (1 mg/kg) | 0 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 60.0 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Phase II (Suspension) Cobimetinib (1 mg/kg) | 0 | Percentage of Participants | ||
| Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Phase I (Tablet) Cobimetinib (0.6 mg/kg) | AEs | 100.0 | Percentage of Participants | |
| Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Phase I (Tablet) Cobimetinib (0.8 mg/kg) | AEs | 100.0 | Percentage of Participants |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow96
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 6 | |
| Overall Study | STARTED | Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 6 | |
| Overall Study | STARTED | Phase I (Tablet) Cobimetinib (1 mg/kg) | 6 | |
| Overall Study | STARTED | Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 6 | |
| Overall Study | STARTED | Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 7 | |
| Overall Study | STARTED | Phase I (Suspension) Cobimetinib (1 mg/kg) | 8 | |
| Overall Study | STARTED | Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 5 | |
| Overall Study | STARTED | Phase II (Suspension) Cobimetinib (1 mg/kg) | 12 | |
| Overall Study | Tumor Type - Neuroblastoma | Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 0 | |
| Overall Study | Tumor Type - Neuroblastoma | Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 0 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 participant flowAdverse events2,192
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 2 | 6 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Phase I (Tablet) Cobimetinib (1 mg/kg) | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 1 | 6 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 0 | 7 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase I (Suspension) Cobimetinib (1 mg/kg) | 0 | 8 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase II (Suspension) Cobimetinib (1 mg/kg) | 3 | 12 | 6 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 0 | 6 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 0 | 6 | 0 |
1 to 10 of 2,192Source ClinicalTrials.gov
See all 2,192 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 0 | 6 |
| Total, all-cause mortality | Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 0 | 6 |
| Total, all-cause mortality | Phase I (Tablet) Cobimetinib (1 mg/kg) | 0 | 6 |
| Total, all-cause mortality | Phase I (Suspension) Cobimetinib (0.6 mg/kg) | 0 | 6 |
| Total, all-cause mortality | Phase I (Suspension) Cobimetinib (0.8 mg/kg) | 0 | 7 |
| Total, all-cause mortality | Phase I (Suspension) Cobimetinib (1 mg/kg) | 0 | 8 |
| Total, all-cause mortality | Phase I (Suspension) Cobimetinib (1.33 mg/kg) | 0 | 5 |
| Total, all-cause mortality | Phase II (Suspension) Cobimetinib (1 mg/kg) | 0 | 12 |
| Total, other adverse events | Phase I (Tablet) Cobimetinib (0.6 mg/kg) | 6 | 6 |
| Total, other adverse events | Phase I (Tablet) Cobimetinib (0.8 mg/kg) | 6 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35715627 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02639546
GET https://conductscience.org/api/trials/v1/NCT02639546/registered?page=2