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NCT02639546 · CITED IN SOURCE DOCUMENTS

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2022-09-16

This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Dose-Limiting Toxicities (DLTs)

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outcome · POSTED

Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

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outcome · POSTED

Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Cobimetinib

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outcome · POSTED

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)

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outcome · POSTED

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)

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outcome · POSTED

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)

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outcome · POSTED

Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II)

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outcome · POSTED

Progression-Free Survival (PFS) as Determined by the Investigator Using mINRC for Participants With Neuroblastoma (Phase I)

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outcome · POSTED

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)

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outcome · POSTED

PFS as Determined by the Investigator Using RECIST v1.1 Criteria for Participants With All Other Tumours (Phase I)

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outcome · POSTED

PFS as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II)

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outcome · POSTED

Recommended Phase II Dose (RP2D) of Cobimetinib

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outcome · POSTED

Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 for Participants With LGG (Phase I and II)

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outcome · POSTED

DOR as Determined by the Investigator RANO Criteria for Participants With LGG (Phase II)

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outcome · POSTED

Overall Survival (OS) for Participants With Neuroblastoma (Phase I)

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outcome · POSTED

OS for Participants With High-Grade Glioma (HGG) (Phase I) and Low-Grade Glioma (LGG) (Phase I and II)

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outcome · POSTED

OS for Participants With All Other Tumours (Phase I)

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outcome · POSTED

Maximum Plasma Concentration Observed (Cmax) of Cobimetinib

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outcome · POSTED

Time to Cmax (Tmax) of Cobimetinib

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outcome · POSTED

Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of Cobimetinib

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outcome · POSTED

Apparent Clearance (CL/F) of Cobimetinib

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * For dose-escalation stage (tablets): age at study entry \>= 6 years to \< 18 years * For dose-escalation stage (suspension): age at study entry \>= 6 months to \< 18 years. Participants \<1 year of age will not be enrolled until \>= 6 participants \>= 1 year to \< 18 years of age have received at least one cycle of therapy with suspension and until safety and pharmacokinetic assessment of these participants have been conducted. * For expansion stage: age at study entry to be \>= 6 months (\>=6 years if suspension is not available) to \< 30 years. Participants \>= 6 months to \< 1 year of age may not be enrolled until \>= 6 participants \>= 1 year to \< 18 years of age have received at least one cycle of therapy with suspension in the dose-escalation phase and until safety and pharmacokinetic assessment of these participants have been conducted. * Tumor for which prior treatment has proven to be ineffective or intolerable or for which no standard therapy exists * Tumor with known or expected RAS/RAF/MEK/ERK pathway involvement. Diagnosis must be one of the following tumor types: Central nervous system gliomas, including high- and low-grade gliomas, and diffuse intrinsic pontine glioma (DIPG) Embryonal rhabdomyosarcoma and other non-rhabdomyosarcoma soft tissue sarcomas Neuroblastoma Melanoma Malignant peripheral nerve sheath tumor Rhabdoid tumors, including atypical teratoid/rhabdoid tumor (ATRT) NF1-associated tumor (including plexiform neurofibroma), schwannoma, or RASopathy-associated tumor that in the judgment of the investigator is life threatening, results in severe symptoms (including severe pain), or is in close proximity to vital structures * Measurable disease as defined by mINRC, RANO criteria for HGG, RANO criteria for LGG, RECIST v1.1, or evaluable by nuclear medicine techniques, immunocytochemistry, tumor markers, or other reliable measures * Availability of tumor tissue at study enrollment * Lansky performance status or Karnofsky performance status of \>= 50 percent * Life expectancy \>= 3 months * Adequate hematologic, cardiac, and end-organ function * Body weight must be \>= 20 kilograms (kg) if suspension is not available Exclusion Criteria: * Pregnant or lactating women * Close proximity in time to treatment with high-dose chemotherapy, stem-cell rescue, differentiation therapy, immunotherapy, thoracic or mediastinal radiotherapy, hormonal therapy, biologic therapy, herbal cancer therapy, hematopoietic growth factor, investigational therapy, or St. John's wort according to protocol-defined criteria prior to initiation of study drug * Inability to swallow oral medications * Impaired gastrointestinal absorption * History or evidence of retinal pathology according to protocol-defined criteria, including serous retinopathy * History of Grade \>= 2 central nervous system (CNS) hemorrhage * History of CNS hemorrhage within 28 days of study entry. This criterion may be waived at the investigator's request if the CNS hemorrhage was asymptomatic, with approval of the Medical Monitor * Known active infection (excluding fungal infection of the nail beds) within 28 days prior to initiation of study drug that has not completely resolved * Major surgical procedure or significant traumatic injury within 4 weeks prior to initiation of study drug, or anticipation of need for major surgical procedure during the course of the study * Prior allogenic bone marrow transplantation or prior solid organ transplantation
healthy Volunteers
false
maximum Age
30 Years
minimum Age
6 Months
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    intervention Names
    1. Drug: Cobimetinib
    label
    Phase I (Tablet) Cobimetinib (0.6 mg/kg)
    type
    EXPERIMENTAL
  2. description
    Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    intervention Names
    1. Drug: Cobimetinib
    label
    Phase I (Tablet) Cobimetinib (0.8 mg/kg)
    type
    EXPERIMENTAL
  3. description
    Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    intervention Names
    1. Drug: Cobimetinib
    label
    Phase I (Tablet) Cobimetinib (1 mg/kg)
    type
    EXPERIMENTAL
  4. description
    Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    intervention Names
    1. Drug: Cobimetinib
    label
    Phase I (Suspension) Cobimetinib (0.6 mg/kg)
    type
    EXPERIMENTAL
  5. description
    Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    intervention Names
    1. Drug: Cobimetinib
    label
    Phase I (Suspension) Cobimetinib (0.8 mg/kg)
    type
    EXPERIMENTAL
  6. description
    Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    intervention Names
    1. Drug: Cobimetinib
    label
    Phase I (Suspension) Cobimetinib (1 mg/kg)
    type
    EXPERIMENTAL
  7. description
    Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    intervention Names
    1. Drug: Cobimetinib
    label
    Phase I (Suspension) Cobimetinib (1.33 mg/kg)
    type
    EXPERIMENTAL
  8. description
    Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    intervention Names
    1. Drug: Cobimetinib
    label
    Phase II (Suspension) Cobimetinib (1 mg/kg)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase I (Suspension) Cobimetinib (0.6 mg/kg)
    2. Phase I (Suspension) Cobimetinib (0.8 mg/kg)
    3. Phase I (Suspension) Cobimetinib (1 mg/kg)
    4. Phase I (Suspension) Cobimetinib (1.33 mg/kg)
    5. Phase I (Tablet) Cobimetinib (0.6 mg/kg)
    6. Phase I (Tablet) Cobimetinib (0.8 mg/kg)
    7. Phase I (Tablet) Cobimetinib (1 mg/kg)
    8. Phase II (Suspension) Cobimetinib (1 mg/kg)
    description
    Cobimetinib tablet or suspension will be administered as per the schedule described in arm description.
    name
    Cobimetinib
    other Names
    1. RO5514041, GDC-0973, XL-518
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
56
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Dose-Limiting Toxicities (DLTs) were defined as cobimetinib-related adverse events occurring within the first 28 days of each administration of cobimetinib.
    measure
    Percentage of Participants With Dose-Limiting Toxicities (DLTs)
    time Frame
    Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
  2. description
    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.
    measure
    Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
    time Frame
    Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
  3. description
    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).
    measure
    Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Cobimetinib
    time Frame
    Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length=28 days)
  4. description
    Tumor assessment was performed using mINRC for Participants with Neuroblastoma.
    measure
    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)
    time Frame
    Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)
  5. description
    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.
    measure
    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)
    time Frame
    Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)
  6. description
    Tumor assessment was performed using RECIST v1.1 for Participants with All Other Tumours.
    measure
    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)
    time Frame
    Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)
  7. description
    Tumor assessment will be performed using RANO criteria for LGG.
    measure
    Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II)
    time Frame
    Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)
  8. description
    Tumor assessment was performed using mINRC for Participants with Neuroblastoma.
    measure
    Progression-Free Survival (PFS) as Determined by the Investigator Using mINRC for Participants With Neuroblastoma (Phase I)
    time Frame
    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)
  9. description
    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.
    measure
    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)
    time Frame
    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)
  10. description
    Tumor assessment was performed using RECIST v1.1 for Participants with All Other Tumours.
    measure
    PFS as Determined by the Investigator Using RECIST v1.1 Criteria for Participants With All Other Tumours (Phase I)
    time Frame
    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)
  11. description
    Tumor assessment was performed using RANO criteria for Participants with LGG.
    measure
    PFS as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II)
    time Frame
    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)
secondary Outcomes
  1. description
    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).
    measure
    Recommended Phase II Dose (RP2D) of Cobimetinib
    time Frame
    Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length=28 days)
  2. description
    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.
    measure
    Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 for Participants With LGG (Phase I and II)
    time Frame
    From first occurrence of objective response to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)
  3. description
    Tumor assessment was performed using RANO criteria for Participants with LGG.
    measure
    DOR as Determined by the Investigator RANO Criteria for Participants With LGG (Phase II)
    time Frame
    From first occurrence of objective response to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)
  4. description
    OS was defined as the time from initiation of study drug to death from any cause.
    measure
    Overall Survival (OS) for Participants With Neuroblastoma (Phase I)
    time Frame
    Baseline until death due to any cause (up to 5 years, 2 months)
  5. description
    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.
    measure
    OS for Participants With High-Grade Glioma (HGG) (Phase I) and Low-Grade Glioma (LGG) (Phase I and II)
    time Frame
    Baseline until death due to any cause (up to 5 years, 2 months)
  6. description
    OS was defined as the time from initiation of study drug to death from any cause.
    measure
    OS for Participants With All Other Tumours (Phase I)
    time Frame
    Baseline until death due to any cause (up to 5 years, 2 months)
  7. description
    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.
    measure
    Maximum Plasma Concentration Observed (Cmax) of Cobimetinib
    time Frame
    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)
  8. description
    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.
    measure
    Time to Cmax (Tmax) of Cobimetinib
    time Frame
    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)
  9. description
    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.
    measure
    Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of Cobimetinib
    time Frame
    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)
  10. description
    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, and within 4 hours prior to dosing on Day 1 of Cycle 2.
    measure
    Apparent Clearance (CL/F) of Cobimetinib
    time Frame
    Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21; pre-dose on Cycle 2 Day 1 (pre-dose=within 4 hours prior to dose; cycle length=28 days)
Full study description
brief Summary
This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.
Source references
references
  1. citation
    Trippett T, Toledano H, Campbell Hewson Q, Verschuur A, Langevin AM, Aerts I, Howell L, Gallego S, Rossig C, Smith A, Patel D, Pereira LR, Cheeti S, Musib L, Hutchinson KE, Devlin C, Bernardi R, Geoerger B. Cobimetinib in Pediatric and Young Adult Patients with Relapsed or Refractory Solid Tumors (iMATRIX-cobi): A Multicenter, Phase I/II Study. Target Oncol. 2022 May;17(3):283-293. doi: 10.1007/s11523-022-00888-9. Epub 2022 Jun 17.
    pmid
    35715627
    type
    DERIVED
Source notices and limitations
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        OTELLIC were assessed, but not established, in a multi-center, open-label, dose-escalation study in 55 pediatric patients aged 2 to 17 years with solid tumors [NCT02639546]. No new safety events were observed in pediatric patients in this trial. Exposure in pediatric patients who received COTELLIC at the maximum tolerated dosage
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      source record id
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      source file sha256
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      payload sha256
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      payload
      application numbers
      1. NDA206192
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
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      link basis
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      nct id
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      occurrences
      1. context exact
        OTELLIC were assessed, but not established, in a multi-center, open-label, dose-escalation study in 55 pediatric patients aged 2 to 17 years with solid tumors [NCT02639546]. No new safety events were observed in pediatric patients in this trial. Exposure in pediatric patients who received COTELLIC at the maximum tolerated dosage
        end
        2458
        exact text
        NCT02639546
        start
        2447
      offset unit
      unicode_code_points
      source file
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      source file sha256
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      source json pointer
      /results/74/use_in_specific_populations/0
      source kind
      fda_spl_label
      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      bd3b626cb994509d24088d133953baa2229e49627422ad874bb262002bc2ac3a
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=300&sort=id%3Aasc
      spl effective time
      20260729
      spl set id
      c387579e-cee0-4334-bd1e-73f93ac1bde6

    Preserved source evidence · Not medical advice