ACTRN12621001183875终止2 期
Single arm, open label, signal seeking, phase II trial of pamiparib in patients with relapsed/ refractory myeloid haematological malignancy with aberrant germline or somatic DNA repair pathway function.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
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
- •Inclusion criteria - participants from Pan cancer subprogram
- •1. Adults, aged 18 years and older, with pathologically confirmed high grade haematological malignancy of any myeloid subtype, including but not limited to AML, MDS and MPN or an earlier diagnosis of a poor prognosis cancer.
- •2. Confirmation of molecular eligibility by the molecular tumour board to have germline or somatic DNA repair pathway mutation (e.g. BRCA1/2, ATM, RAD1/2, PALB2), and/or BRCA mutational signature.
- •3. ECOG performance status 0-2.
- •4. Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists;
- •5. Measurable disease assessed within 28 days prior to registration. Percentage bone marrow infiltration or circulating myeloid blast cells may be used as a surrogate for measurable disease.
- •6. Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
- •a. bone marrow function; platelets greater than or equal to 100 x 10^9/L, ANC greater than or equal to 1.5 x 10^9/L, and haemoglobin greater than or equal to 9g/dL (5.6mmol/L),; except where bone marrow function is reduced as a result of the underlying disease;
- •b. liver function; ALT/AST less than or equal to 3 x ULN and total bilirubin less than or equal to 1.5xULN; patients with Gilberts syndrome less than or equal to 4 x ULN
- •c. renal function; serum creatinine calculated GFR (glomerular filtration rate) greater than 30ml/min
- •7. Sufficient and accessible tissue (Bone marrow aspirate) less than 3 months old for exploratory objectives
- •8. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- •9. Signed, written informed consent to participation in the specific treatment substudy.
- •10. Life expectancy of at least 12 weeks
排除标准
- •1. Previous treatment with a PARP inhibitor;
- •2. Known history of hypersensitivity or contraindication to pamiparib;
- •3. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the investigational product(s) as assessed by the treating physician;
- •4. Co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
- •5. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment:
- •a. Radiation therapy, within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions;
- •b. Immunotherapy within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment;
- •c. Chemotherapy, biologic therapy, or hormonal therapy within 7 days or 5 half-lives of a drug prior to the first dose of study treatment or until recovery from previous therapy (whichever is longer);
- •d. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- •6. Administration of any investigational treatment within 28 days prior to receiving the first dose of pamiparib
- •7. Any unresolved toxicity (greater than CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy);
- •8. Known history of active tuberculosis
- •9. Receipt of live attenuated vaccination within 30 days prior to study entry
- •10. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
- •11. Has difficulty with or is unable to swallow oral medication, or has gastrointestinal disease that would limit the absorption of oral medication
- •12. Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer
- •13. Eligible for participation in another MoST substudy based on identification of an actionable mutation. Patients who have previously participated in another MoST substudy may subsequently participate in this study, all other inclusion and exclusion criteria being satisfied.
- •14. Any of the following cardiovascular criteria:
- •a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, within 28 days prior to registration
- •b. Symptomatic pulmonary embolism within 28 days prior to registration
- •c. Any history of acute myocardial infarction within 6 months prior to registration
- •d. Any history of heart failure meeting New York Heart Association Classification III or IV within 6 months prior to registration
- •e. Any event of ventricular arrhythmia greater than or equal to Grade 2 in severity within 6 months prior to registration
- •f. Any history of cerebral vascular accident within 6 months prior to registration
研究者
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