EUCTR2017-000878-11-BE进行中（未招募）1 期
A modular, multi-arm, multi-part, first time in patient study to evaluate the safety and tolerability of OMO-1, alone and in combination with anti-cancer treatments, in patients with locally advanced, unresectable or metastatic solid malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Aged at least 18 years.
- •Provision of signed and dated, written informed consent.
- •Histological or cytological confirmation of locally advanced,
- •unresectable or metastatic solid malignancy
- •Performance status: Eastern Co-operative Oncology Group (ECOG) =1
- •and life expectancy =3 months.
- •Patients must have recovered from toxicities of prior therapies (i.e.
- •CTCAE Grade =1).
- •Ability to swallow and retain oral medication.
- •Adequate organ functions.
- •Not receiving other cancer therapy, or other investigational product,
- •apart from the combination agent(s) described in the relevant
- •combination module(s).
- •No radiotherapy for the primary tumour within 1 week from
- •screening visit.
- •Not receiving medications predominantly metabolized by CYP2B6.
- •Washout period for medications predominantly metabolized by CYP2B6,
- •apart for tamoxifen, is 7 days prior to the first dose of study treatment.
- •Washout period for tamoxifen is 2 months prior to the first dose of study
- •Not receiving cannabinoid substances and St. John's Wort.
- •Washout period for cannabinoid substances and St. John's Wort is 5 and
- •7 days respectively prior to the first dose of study treatment.
- •Not receiving medication that are known to have potent aldehyde
- •oxidase (AO) inhibitory activity.
- •Washout period for medications that are known to have potent AO
- •inhibitory activity is 7 days prior to the first dose of study treatment.
- •No prior splenectomy.
- •No current or history of uveitis.
- •No known uncontrolled inter-current illness including ongoing or
- •active infections, symptomatic congestive heart failure, conditions that
- •could adversely be affected by hypertension or tachycardia, unstable
- •angina pectoris, cardiac arrhythmia, or psychiatric illness/social
- •situations that would limit compliance with study requirements.
- •No history or clinical evidence of neoplastic central nervous system
- •(CNS) involvement if not stable for 9 weeks prior to the first dose of
- •study treatment.
- •Note: Patients with glioblastomas are allowed if their symptoms are
- •No current or history of, any seizure or seizure disorder. This includes
- •receiving, or having received, seizure threshold-raising medication for
- •the treatment of epilepsy.
- •In addition to the main core eligibility criteria, module specific eligibility
- •criteria include:
- •Patient recruited into the sequential biopsy cohorts of Part A:
- •At least 1 lesion suitable for biopsy.
- •Tumours that are MET gene amplified and/or mutated.
- •(MET gene amplified and/or mutated status defined in the laboratory
- •No prior therapy with a selective MET inhibitor.
- •Patients recruited into Part B cohorts:
- •Tumours that are MET gene amplified and/or mutated.
- •(MET gene amplified and/or mutated status defined in the laboratory
- 另有 12 项未显示
排除标准
- •1. Patients receiving other cancer therapy, or other investigational
- •product, apart from the combination agent(s) described in the relevant
- •combination module(s).
- •Bisphosphonates and granulocyte-colony stimulating factor (GCSF) are
- •acceptable.
- •Immunotherapy's such as mAbs, interferons and cytokines should not be
- •taken other than the combination therapy agent. Immunosuppressant's
- •such as cyclosporine, rapamycin, tacrolimus, rituximab, alemtuzumab,
- •natalizumab etc, should not be taken other than the combination therapy
- •Hormone replacement therapy (HRT) and stable treatment of >6 months
- •with luteinizing hormone releasing hormone (LHRH) analogues are
- •acceptable.
- •During the study period, patients using HRT and bisphosphonates should
- •maintain a constant dose and should not change existing regimen.
- •However, if a change in HRT is indicated, e.g. due to intolerable adverse
- •effects, the regimen may be modified but change should be minimized
- •thereafter.
- •Washout period for cytotoxic drugs and other mAbs is 21 days prior to
- •the first dose of study treatment. Washout period for approved
- •molecular targeted non-cytotoxic drugs is 5 half-lives prior to the first
- •dose of study treatment.
- •2. Patients who have received radiotherapy for the primary tumour
- •within 1 week from screening visit.
- •3. Patients receiving medications predominantly metabolized by
- •CYP2B6 (refer to Section 12.1 for more information).
- •Washout period for medications predominantly metabolized by CYP2B6,
- •apart for tamoxifen, is 7 days prior to the first dose of study treatment.
- •Washout period for tamoxifen is 2 months prior to the first dose of study
- •4. Patients receiving cannabinoid substances.
- •Washout period for cannabinoid substances is 5 days prior to the first
- •dose of study treatment.
- •5. Patients receiving St. John's Wort.
- •Washout period for St. John's Wort is 7 days prior to the first dose of
- •study treatment.
- •6. Patients receiving medications that are known to have potent AO
- •inhibitory activity (refer to Section 12.1 for more information).
- •Washout period for medications that are known to have potent AO
- •inhibitory activity is 7 days prior to the first dose of study treatment.
- •7. Patients with prior splenectomy.
- •8. Patients testing positive for human immunodeficiency virus (HIV)
- •infection, hepatitis B based on findings of persistent hepatitis B virus
- •surface antigen (HBsAg) or other serology test, hepatitis C virus (HCV)
- •or Epstein-Barr Virus (EBV) infection.
- •9. Patients with current, or a history of, uveitis.
- •10. Patients with any known uncontrolled inter-current illness including
- •ongoing or active infections, symptomatic congestive heart failure,
- •conditions that could adversely be affected by hypertension or
- •tachycardia, unstable angina pectoris, cardiac arrhythmia, or psychiatric
- •illness/social situations that would limit compliance with study
- •requirements.
- 另有 11 项未显示
研究者
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