ACTRN12623001216606招募中2 期
Single-institution, single-arm, open-label phase II basket study investigating the effect of mutation and/or elevated hedgehog (Hh) expression-directed smoothened inhibitor sonidegib in patients with advanced solid malignancies
orthern Sydney Local Health District0 个研究点目标入组 20 人开始时间: 2023年11月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Part 1 - Biomarker Screening:
- •Advanced solid organ malignancy, with the exception of basal cell carcinoma
- •Equal to or more than 18 years old
- •ECOG 2 or less
- •At least 1 line of prior systemic therapy (on active treatment allowed)
- •RECIST v1.1 measurable disease
- •Archival tissue (FFPE, core biopsy or unstained slides) for NGS and Hh expression testing
- •Signed consent to screen for NGS and elevated Hh expression (blood and tissue)
- •Part 2 - Interventional Study (following fulfilment of criteria specified for part 1, further inclusion criteria for treatment with Sonidegib):
- •Presence of tumour SMO/PTCH1 mutation, or elevated tissue or serum Hh expression found through screening, or pre-identified on prior commercial NGS panel
- •At least one line of prior systemic therapy (where standard of care systemic therapy exists)
- •Radiologic confirmed measurable disease as per RECIST Version 1.1 (confirmed equal to or more than 28 days prior to enrollment)
- •Prior palliative radiotherapy is permissible if completed equal to or more than 14 days prior to Sonidegib treatment to areas which are not included in response assessment
- •Adequate bone marrow function (e.g. platelets more than 100 x 109/L, ANC equal to or more than 1.5 x 109/L, Hb equal to or more than 90)
- •Adequate renal function (e.g. creatinine clearance equal to or more than 50 ml/min, serum creatinine less than or equal to 1.5 x ULN)
- •Adequate liver function (e.g. ALT/AST equal or less than 3 x ULN or equal to or less than 5 x ULN if liver metastases are present, bilirubin equal to or less than 2 x ULN)
- •Adequate cardiac function (e.g ECG and echocardiogram if clinically indicated)
- •Study treatment both planned and able to start within 28 days of confirmation of SMO or PTCH1 mutation, or elevated hedgehog expression
- •Signed, written informed consent (for trial inclusion and tissue collection)
- •Prior, part 2, screen failure patients are eligible for re-screening for Part 2
排除标准
- •Exclusion criteria for Part 2 - Interventional Study:
- •Prior Sonidegib therapy
- •SMO mutation detected via NGS with known resistance to sonidegib (see supplementary materials)
- •No prior systemic anticancer therapy
- •Life expectancy less than or equal to 3 months
- •Untreated or non-clinically stable CNS disease [patients with asymptomatic, treated and clinically stable CNS disease, including leptomeningeal disease will be eligible]
- •Patients with neuromuscular disorders associated with elevated CK (i.e. inflammatory myopathy)
- •Concomitant therapy with drugs that are recognised to cause rhabdomyolysis
- •Concomitant therapy with drugs that are strong CYP3A4/5 inducers or inhibitors, that are deemed medically necessary
- •Significant uncontrolled infection including hepatitis B, hepatitis C and HIV (patients with treated and stable viral hepatitis may be eligible)
- •Concurrent illness which may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •Comorbid malabsorption syndrome which may impact absorption of study drug
- •Serious medical or psychiatric comorbidity which may limit the ability of a patient to comply with the protocol
- •Prior history of another malignancy in the 2-year period preceding registration. Patients with adequately treated carcinoma-in-situ, basal cell carcinoma or squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder or curatively treated cervical carcinoma in situ will be eligible.
- •Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, or use adequate means of contraception (e.g. barrier method, oral contraceptive pill, intra-uterine device (IUD), or implant). Women of childbearing age must have a negative pregnancy test done within 7 days prior to starting treatment, if eligible for part 2 of this study. Men must have been surgically sterilised or use a barrier method of contraception.
- •An inability to travel to the enrolled site to participate in the trial and all required visits.
研究者
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