NL-OMON44717撤回2 期
A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS - GO29665
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 2
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •Patients must meet the following criteria for study entry:
- •- Signed Informed Consent Form
- •- Signed Child's Informed Assent, when appropriate as determined by patient's age and individual site and country standards
- •- 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
- •Patients <1 year of age will not be enrolled until * 6 patients *1 year to <18 years of age have received at least one cycle of therapy with suspension and until safety and PK assessment of these patients has been conducted.
- •- For expansion stage: Age at study entry * 6 months (* 6 years if suspension is not available) to < 30 years
- •Patients * 6 months to < 1 year of age may not be enrolled until * 6 patients *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 PK assessment of these patients has been conducted.
- •In exceptional cases of relapsed pediatric tumors in patients * 30 years of age, the Sponsor will consider waiving the age requirement with approval of the Medical Monitor. This waiver is restricted to patients with pediatric-specific diseases (e.g., neuroblastoma) for whom clinical trials are unlikely to be available, and will not be extended to patients with tumors that typically occur both in children and adults (e.g., HGG). The Sponsor may decide to stop enrollment of patients * 18 years of age at any time during the study to ensure adequate enrollment of patients < 18 years of age.
- •- Able to comply with the requirements of the study protocol, in the investigator*s judgment
- •- Tumor for which prior treatment has proven to be ineffective (i.e., relapsed or refractory) 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
- •Malignant peripheral nerve sheath tumor
- •Rhabdoid tumors, including atypical teratoid/rhabdoid tumor
- •Tumors from the following groups that, in the judgment of the investigator, are life threatening, resulting in severe symptoms (including severe pain), or are in close proximity to vital structures:
- •Neurofibromatosis 1 (NF1)-associated tumors (including plexiform neurofibroma)
- •Any solid tumor or brain tumor that occurs in a patient with another RASopathy (such as Noonan syndrome)
- •Any solid or brain tumor that has been molecularly profiled and shown to have RAS/RAF/MEK/ERK pathway activation, with approval of the Medical Monitor.
- •- Tumor diagnosis must be histologically or cytologically confirmed either at the time of diagnosis or at the time of relapse, except in the following scenario:
- •DIPG and optic pathway gliomas do not require histologic confirmation if radiographic findings are sufficient to make diagnosis and institutional standard of care does not mandate biopsy for diagnosis.
- •- Current disease state for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
- •- Disease that is measurable as defined by mINRC, RANO criteria, or RECIST v1.1 (as a
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •- Pregnant or lactating, or intending to become pregnant during the study
- •Females of childbearing potential must have a negative serum pregnancy test result within 1 week prior to initiation of study drug.
- •- Prior treatment with cobimetinib or other MEK inhibitor (prior sorafenib use is permissible)
- •- Treatment with high-dose chemotherapy and stem-cell rescue (autologous stem cell transplant) within 3 months prior to initiation of study drug
- •- Treatment with chemotherapy (other than high-dose chemotherapy as described above) or differentiation therapy (such as retinoic acid) or immunotherapy (such as anti-GD2 antibody treatment) within 4 weeks prior to initiation of study drug or, if treatment included nitrosoureas, within 6 weeks prior to initiation of study drug. This requirement may be waived at the investigator*s request if the patient has recovered from therapeutic toxicity to the degree specified in the protocol, with approval of the Medical Monitor.
- •- with thoracic or mediastinal radiotherapy within 6 weeks prior to initiation of study drug
- •- Treatment with hormonal therapy (except hormone replacement therapy or oral contraceptives), immunotherapy, biologic therapy, or herbal cancer therapy within 4 weeks or < 5 half-lives, whichever is shorter, prior to initiation of study drug
- •- Treatment with a long-acting hematopoietic growth factor within 2 weeks prior to initiation of study drug or a short-acting hematopoietic growth factor within 1 week prior to initiation of study drug
- •- Treatment with investigational therapy (with the exception of cancer therapies as described above) within 4 weeks prior to initiation of study drug
- •- Requirement for initiation of corticosteroids or an increase in the dose of corticosteroids within 1 week prior to initiation of study drug
- •- Treatment with St. John's wort or hyperforin or drugs that are strong inhibitors or inducers of CYP3A within 1 week prior to initiation of study drug
- •- Ingestion of grapefruit juice within 1 week prior to initiation of study drug
- •- Any toxicity (excluding alopecia and ototoxicity) from prior treatment that has not resolved to Grade * 1 (per NCI CTCAE v4.0) at screening except as otherwise permitted in the inclusion/exclusion criteria
- •- 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
- •Placement of a vascular access device or minor surgery is permitted if the site has healed prior to initiation of study drug.
- •- Known active infection (excluding fungal infection of the nail beds) within 28 days prior to initiation of study drug that has not completely resolved
- •- History of Grade * 2 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.
- •- For brain tumor patients, use of anticoagulants within 1 week of study drug initiation.
- •- History or evidence of retinal pathology on ophthalmologic examination that is considered to be a risk factor for or indicative of neurosensory retinal detachment, central serous chorioretinopathy, neovascular retinopathy, or retinopathy of prematurity
- •- Known hypersensitivity to any compo
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