NL-OMON53837招募中2 期
Brightline-1: A Phase II/III, randomized, openlabel, multi-center study of brigimadlin (BI 907828) compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma. - A study to test brigimadlin in people with DDLPS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of signed and dated, written informed consent form ICF in
- •accordance with ICH-GCP and local legislation prior to any trial-specific
- •procedures, sampling, or analyses.
- •2. Male or female patients >=18 years old at the time of signature of the ICF.
- •Women of childbearing potential and men able to father a child must be ready
- •and able to use 2 medically acceptable methods of birth control per ICH M3 (R2)
- •that result in a low failure rate of less than 1% per year when used
- •consistently and correctly beginning at screening, during trial participation,
- •and until 6 months and 12 days after last dose.
- •3. Histologically proven locally advanced or metastatic, unresectable (surgery
- •morbidity would outweigh potential benefits), progressive or recurrent DDLPS.
- •Locally performed histopathological diagnosis will be accepted for entry into
- •this trial but will be confirmed by independent pathological review while the
- •patients receive treatment in this trial.
- •4. Written pathology report indicating the diagnosis of DDLPS with positive
- •MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence
- •in situ hybridization or NGS must be available.
- •5. Formalin fixed paraffin embedded tumor blocks or slides must be available
- •for retrospective histopathological central review.
- •6. Presence of at least one measurable target lesion according to RECIST
- •version 1.1. In patients who only have one target lesion, the baseline imaging
- •must be performed at least 2 weeks after any biopsy of the target lesion.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- •8. Patient must be willing to donate blood samples for the pharmacokinetics,
- •pharmacodynamics, and tumor mutation analysis.
- •9. Patient willing to undergo a mandatory tumor biopsy at the time point
- •specified in the flowchart unless exempt.
- •10. Adequate organ function.
排除标准
- •1. Known mutation in the TP53 gene (screening for TP53 status is not required).
- •2. Major surgery (major according to the investigator*s assessment) performed
- •within 4 weeks prior to randomization or planned within 6 months after
- •3. Prior systemic therapy for liposarcoma in any setting (including adjuvant,
- •neoadjuvant, maintenance, palliative).
- •4. Previous or concomitant malignancies other than DDLPS or WDLPS, treated
- •within the previous 5 years, except effectively treated non-melanoma skin
- •cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other
- •malignancy that is considered cured by local treatment.
- •5. Previous treatment with anthracyclines in any setting (systemic treatment
- •with other anti-cancer agents is allowed if completed at least 5 years prior to
- •study entry with the exception of hormone therapy).
- •6. Patients who must or intend to continue the intake of restricted medications
- •or any drug considered likely to interfere with the safe conduct of the trial.
- •7. Currently enrolled in another investigational device or drug trial, or less
- •than 30 days since ending another investigational device or drug trial(s) or
- •receiving other investigational treatment(s).
- •8. Patients not expected to comply with the protocol requirements or not
- •expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse
- •or any other condition that, in the investigator*s opinion, makes the patient
- •an unreliable trial participant).
- •9. Women who are pregnant, nursing, or who plan to become pregnant while in the
- •trial; female patients who do not agree to the interruption of breast feeding
- •from the start of study treatment until six months and 12 days after last dose
- •of study treatment.
- •10. Patients with known history of human immunodeficiency virus (HIV) infection
- •(see protocol for more details).
- •11. Patients with a history of HCV infection (see protocol for more details).
- •12. Patients with chronic HBV infection (see protocol for more details).
- •13. Any history or presence of uncontrolled gastrointestinal disorders that
- •could affect the intake and/or absorption of the trial drug (e.g. nausea,
- •vomiting, Crohn*s disease, ulcerative colitis, chronic diarrhoea,
- •malabsorption) in the opinion of the investigator.
- •14. Known hypersensitivity or contraindication to the trial drugs or their
- •excipients.
- •15. Active major infection requiring systemic treatment (antibacterial,
- •antiviral, or antifungal therapy) at treatment start in this trial.
- •16. History or presence of cardiovascular abnormalities such as uncontrolled
- •hypertension, congestive heart failure NYHA classification of >=III or IV,
- •unstable angina or poorly controlled arrhythmia which are considered as
- •clinically relevant by the investigator. Myocardial infarction of stroke within
- •6 months prior to randomization.
- •17. Any cardiac criteria (see protocol for more details).
- •18. Patients with brain metastasis (see protocol for more details).
- •19. Active bleeding, significant risk of haemorrhage (e.g. previous severe
- •gastrointestinal bleeding, previous haemorrhagic stroke at any time), or
- •current bleeding disorder (e.g. haemophilia, von Willebrand disease).
- •20. Any history of, or concomitant condition that, in the opinion of the
- •investigator, would compromise the patient*s ability to comply with the tria
研究者
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