EUCTR2018-004497-10-IT进行中（未招募）1 期
Phase 2 randomized trial of trabectedin + olaparib vs. trabectedin in advanced, metastatic or unresectable soft tissue sarcoma after failure of standard treatments - TOMAS-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
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
- •*Written informed consent prior to any study specific procedures.
- •*Histologically documented and not surgically resectable or metastatic STS that progressed after first- or further-line treatments for relapsing disease.
- •*At least one previous line of anthracycline-containing chemotherapy for advanced disease or relapsed/progressed within 6 months of a previous treatment with an anthracycline-containing chemotherapy in the neo-adjuvant/adjuvant setting.
- •*Measurable disease according RECIST 1.1
- •*ECOG Performance Status of 0 or 1. Patients with an ECOG 2 are eligible if it depends solely on orthopedic problems.
- •*Estimated life expectancy of at least 16 weeks.
- •*Age >=18 years.
- •*Left Ventricular Ejection Fraction = 50% and/or above lower institutional limit of normality
- •*Adequate bone marrow, liver and renal function assessed within 7 days prior to day1Cy1
- •*Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •*Participation in another study in the last 4 weeks.
- •* Previous treatment with trabectedin, olaparib or other Poly Adpribose polymerase 1 (PARP-1) inhibitors
- •*Persistent toxicities G2 with the exception of alopecia
- •*Significantly mental status that would prevent the understanding of informed consent and compliance
- •*Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 6 months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis or severely impaired lung function.
- •* Immune compromised patients, e.g., patients who are known to be y positive for HIV.
- •* Active clinically serious infections (> grade 2 CTCAE).
- •* Active viral hepatitis
- •*Metastatic brain or meningeal tumors
- •*Patients with seizure disorders requiring medication
- •*Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 28 days before the start of treatment.
- •* Patients with evidence or history of bleeding diathesis.
- •*Patients undergoing renal dialysis.
- •* Patients unable to swallow oral medications.
- •*Uncontrolled diabetes
- •*Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent
- •*Other malignancy unless curatively treated with no evidence of disease for =5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ , Stage 1, grade 1 endometrial carcinoma. Patients with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
- •*Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs).
- •*Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
- •*Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
- •*Major surgery within 4 weeks of start of study. Thus, patients must have recovered from wound or directly surgical related complications at time of study randomization.
- •*Investigational drug therapy outside of this trial during or within 4 weeks of study entry.
- •*Patients with known hypersensitivity to trabectedin, olaparib or to their excipients.
- •*Patients can receive a stable dose of bisphosphonates for bone metastases before and during the study as long as these were started at least 4 weeks prior to treatment with the study drugs.
- •*Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- •* A history of noncompliance to medical regimens or inability or unwillingness to return for scheduled visits.
- •* Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator , or patients with congenital long QT syndrome.
- •* Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors . The required washout perio
研究者
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