EUCTR2011-005533-39-HU进行中（未招募）不适用
A Phase I-II evaluation of the safety and efficacy of the oral HSP90 inhibitor Debio 0932 in combination with standard of care in first- and second-line therapy of patients with Stage IIIb or IV Non-small Cell Lung Cancer - the HALO study (HSP90 inhibition And Lung cancer Outcomes) - HALO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 298
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
- •1. Age = 18 years;
- •2. Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known EGFR mutation;
- •3. Archived tumour sample available;
- •4. Advanced or metastatic disease (Stage IIIb or IV) ;
- •5. Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if > 6 months ago); Patients to be treated with docetaxel: = 1 previous treatment with chemotherapy.
- •6. Candidate for treatment with cisplatin/pemetrexed or cisplatin/gemcitabine or docetaxel as determined by the Investigator;
- •7. Measurable disease by the RECIST criteria;
- •8. ECOG performance score 0 - 1;
- •9. Life expectancy = 3 months;
- •10. ANC = 1 500/µL;
- •11. Platelets = 100 000/µL;
- •12. Creatinine clearance = 60 mL/minutes (Cockroft – Gault formula);
- •13. AST and ALT = 2.5 x ULN; in case of documented liver metastases, AST and ALT = 3.5 x ULN;
- •14. LVEF = 55% on cardiac ultrasound;
- •15.If female, neither pregnant nor lactating;
- •16. Women of child-bearing potential:
- •a. Negative pregnancy test at screening;
- •b. Agreement to use appropriate contraception methods from study entry to 6 months after the last day of treatment.
- •17. Male patients agree to use contraception methods from study entry to 6 months after the last day of treatment;
- •18. Provide written informed consent;
- •19. Ability to comply with study procedures.
- •1. Age = 18 years;
- •2. Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known EGFR mutation, and with known KRAS status;
- •3. Archived tumour sample available;
- •4. Advanced or metastatic disease (Stage IIIb or IV) ;
- •5. No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if > 6 months ago) ;
- •6. Candidate for treatment with cisplatin/pemetrexed or cisplatin/gemcitabine as determined by the Investigator;
- •7. Measurable disease by the RECIST criteria;
- •8. ECOG performance score 0 - 1;
- •9. Life expectancy = 3 months;
- •10. Absolute neutrophil count = 1 500/µL;
- •11. Platelets = 100 000/µL;
- •12. Creatinine clearance = 60 mL/minutes (Cockroft – Gault formula);
- •13. AST and ALT = 2.5 x ULN; in case of documented liver metastases, AST and ALT = 3.5 x ULN;
- •14. LVEF = 55% on cardiac ultrasound;
- •15. If female, neither pregnant nor lactating;
- •16. Women of child-bearing potential:
- •a. Negative pregnancy test at screening;
- •b. Agreement to use appropriate contraception methods from study entry to 6 months after the last day of treatment.
- •17. Male patients agree to use contraception methods from study entry to 6 months after the last day of treatment;
- •18. Provide written informed consent;
- •19. Ability to comply with study procedures.
- •1. Age = 18 years;
- •2. Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known EGFR mutation, and with known KRAS status;
- •3. Archived tumour sample available unless previous participant in Part B;
- •4. Advanced or metastatic disease (Stage IIIb or IV) ;
- •5. One of these two criteria should be fulfilled:
- •a. Previous participant of Part B with PD under study treatment OR
- •b. New patient in case of futility of the interim analysis of Part B or in case of an insufficient number of patients enrolling from Part B with PD after dual chemotherapy with cisplatin/pemetrexed or cisplatin/gemcitabine or for any other reason.
排除标准
- •1. Unresolved toxicity from previous treatment;
- •2. Symptomatic brain metastases;
- •3. For patients on docetaxel: Serum bilirubin levels > ULN associated with serum ALP levels > 6 times ULN;
- •4. Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease);
- •5. Concurrent treatment with any other systemic anti-cancer therapy;
- •6. Concomitant treatment with any drug on the prohibited medication list (provided separately);
- •7. Serious concomitant uncontrolled medical conditions.
- •1. Unresolved toxicity from previous treatment;
- •2. Symptomatic brain metastases;
- •3. Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease);
- •4. Concurrent treatment with any other systemic anti-cancer therapy;
- •5. Concomitant treatment with any drug on the prohibited medication list (provided separately);
- •6. Serious concomitant uncontrolled medical conditions.
- •1. Unresolved toxicity from previous treatment;
- •2. Symptomatic brain metastases;
- •3. Serum bilirubin levels > ULN associated with serum ALP levels > 6 times ULN;
- •4. Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease) ;
- •5. Concurrent treatment with any other systemic anti-cancer therapy;
- •6. Concomitant treatment with any drug on the prohibited medication list (provided separately);
- •7. Serious concomitant uncontrolled medical conditions.
研究者
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