ACTRN12619001265167招募中2 期
Single arm, open label, signal seeking, phase IIa trial of the activity of Trastuzumab emtansine (T-DM1) in patients with tumours harbouring HER2 amplifications or mutations
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
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
- •1. Adults, aged 18 years and older, with either pathologically confirmed:
- •a. advanced and/or metastatic solid cancer of any histologic type, refractory or unsuitable for standard therapies for that cancer type; or
- •b. metastatic, non-squamous NSCLC
- •2. Patients with tumours harbouring HER2 mutations or amplification (in the absence of a mutation) (Groups 1 and 2) or HER2 mutation with/without amplification (Groups 3 and 4) identified using comprehensive genomic profiling (CGP) and determined by the molecular tumour board.
- •3. Confirmation of molecular eligibility by the molecular tumour board
- •4. Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and/or RANO. (Exception: ASPiRATION participants with evaluable but non-measurable disease may be approved on a case-by-case basis by contacting the ASPiRATION study chair or delegate through the NHMRC CTC).
- •5. ECOG 0-2
- •6. If the CNS is involved (either primary or metastatic disease), this must be asymptomatic or previously treated and controlled either with local treatment or by steroids
- •7. 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 equal or more than 100 x 10^9/L, ANC equal or more than 1.5 x 10^9/L, and haemoglobin equal or more than 9g/dL (5.6mmol/L);
- •b. liver function; ALT/AST equal or less than 2.5 x ULN and total bilirubin equal or less than 1.5xULN;
- •c. renal function: creatinine clearance greater than 50 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR) estimation: (140 - Age) × (weight in kg) × (0.85 if female)/(72 × serum creatinine);
- •8. Prior anticancer therapy (excluding HER2 inhibitors)
- •a. For newly diagnosed metastatic, non-squamous NSCLC:
- •i. Up to 2 cycles of systemic therapy while awaiting the results of CGP testing are permitted (but not required);
- •b. For second or subsequent line metastatic, non-squamous NSCLC:
- •i. Clinical or radiological progression on, or following last anticancer therapy unless such anticancer therapy stopped due to toxicity / treatment intolerance
- •c. For advanced and/or metastatic treatment-refractory solid cancer of any histologic type:
- •i. Participants must have received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists.
- •ii. Clinical or radiological progression on, or following last anticancer therapy unless such anticancer therapy stopped due to toxicity / treatment intolerance
- •9. ALP equal or less than 2.5 ×ULN with the following exception: patients with bone metastases: ALP equal of less than 5 ×ULN
- •10. INR and aPTT less then 1.5 x ULN (unless on therapeutic coagulation)
- •11. Albumin equal or more than 25mg/dL
- •12. Life expectancy greater than or equal to 12 weeks
排除标准
- •1.Known history of hypersensitivity or contraindication to T-DM1;
- •2.Prior treatment with T-DM1, or other HER2-directed therapy;
- •3.HER2-amplified breast and gastric cancer (breast and gastric cancer with HER2 mutations are permitted);
- •4.Peripheral neuropathy of grade 2 or higher (according to National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 5);
- •5. History of recent (within 3 months prior to screening) symptomatic congestive heart failure or clinically significant cardiac dysfunction as determined by left ventricular ejection fraction (LVEF) less than 50%;
- •6.Currently diagnosed with interstitial lung disease, interstitial fibrosis or history of tyrosine kinase inhibitor-induced pneumonitis
- •7.Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the investigational product(s);
- •8.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;
- •9.Radiation therapy, major surgery or tumour embolization within 14 days prior to the first dose of T-DM1;
- •10.Any systemic therapy within 28 days prior to the first dose of T-DM1. Any systemic therapy within 21 days prior to the first dose of T-DM1 for ASPiRATION cohort participants who received systemic therapy while awaiting the results of CGP testing.;
- •11.Any unresolved toxicity ( greater than CTCAE v5.0 grade 2) from previous anti-cancer therapy;
- •12.Prior or concurrent malignancy except for:
- •a.Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence;
- •b.Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;
- •c.Adequately treated carcinoma-in-situ without evidence of disease
- •13.Pregnancy, lactation, or inadequate contraception.
研究者
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