EUCTR2017-001655-31-GB进行中（未招募）1 期
A Phase III Study of AL3818 (Catequentinib, Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma - Anlotinib in Sarcoma, Version 2.1 15-October-2019
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
- 325
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. Patients who are able to sign inform consent
- •2. Male or female at least 18 years of age
- •3. Indication A – ASPS: Histologically proven, unresectable, locally advanced or metastatic alveolar soft part sarcoma.
- •Indication C – SS: Histologically proven, unresectable, recurrent, locally advanced or metastatic synovial sarcoma.
- •Indication D – LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, and vascular origin).
- •4. Indication A – ASPS: Subjects with or without prior therapy.
- •Indication C – SS: Subjects previously treated with at least one prior line of standard systemic therapy, including first-line anthracycline containing regimen
- •Indication D – LMS: Treatment of patients with metastatic or advanced leiomyosarcoma (LMS) who have failed at least one prior line of standard therapy and are ineligible for or refuse standard second-line therapy or are suitable for third- and further-line treatment.
- •5. Show clinical or objective disease progression after the last administration of the last standard therapy or have stopped standard therapy due to intolerability within 6 months of enrollment
- •6. ECOG 0 or 1
- •7. Measurable disease as per RECIST 1.1
- •8. Life expectancy of at least 3 months
- •9. Female of childbearing potential - negative test at screening and male and female participants willing to use contraception
- •10. Adequate hematologic, hepatic and renal function as assessed by the following laboratory requirements conducted within 28 days of enrollment
- •11. Left ventricular ejection fraction (LVEF) of > 50% by ECHO or MUGA within 56 days of enrollment
- •12. Two readings of systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg at screening taken at least 5 minutes apart in the sitting position after 5 minutes of rest.
- •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 268
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •1. Prior treatment with or have known hypersensitivity to AL3818
- •2. Indication A – ASPS: Prior treatment with cediranib
- •Indication C – SS: Prior treatment with or have known hypersensitivity to dacarbazine.
- •Indication D – LMS: Prior treatment with anlotinib.
- •3. Previous or concurrent cancer that is distinct in primary site or histology from ASPS, LMS, or SS within 5 years before enrollment except for successfully treated in situ carcinoma, non-melanoma skin cancer and superficial bladder tumors (Ta, Tis and T1).
- •4. Received last dose of systemic cytotoxic therapy or investigational therapy within 21 days of enrollment or last dose of hormonal therapy, immunotherapy, targeted therapy or any other type of non-cytotoxic anti-cancer therapy within 14 days of enrollment.
- •5. Prior treatment with extended-field radiotherapy (EFRT) within 28 days of enrollment or prior treatment with any other form of radiotherapy within 14 days of enrollment.
- •6. Known active CNS metastases and/or carcinomatous meningitis. Patients with brain mets who are stable can be considered.
- •7. Cavitary tumors or tumors invading or abutting large blood vessels in the thorax.
- •8. History of gastrointestinal perforation, abdominal fistula or intra-abdominal abscess within 6 months of enrollment.
- •9. Known history of bleeding disorders
- •10. Clinically significant bleeding
- •11. CTCAE version 4.03 > grade 2 pulmonary hemorrhage or > grade 3 of other forms of bleeding within 28 days prior to enrollment
- •12. History of untreated deep venous thrombosis (DVT) within the past 6 months
- •13. Use of aspirin (>325 mg/day) within 10 days prior to the first dose of study treatment
- •14. Serious non-healing wound, active ulcer
- •15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment or minor surgical procedure within 7 days of enrollment
- •16. CTCAE version 4.03 > grade 3 peripheral neuropathy
- •17. Any unrecovered toxicity reactions of CTCAE version 4.03 > grade 1 caused by any previous therapy
- •18. QTcF > 470 msec (per Fridericia’s formula) on electrocardiogram within 28 days of enrollment
- •19. Severe and uncontrolled disease: Class I and above myocardial ischemia or myocardial infarction, cardiac arrhythmia and Class 2 or above congestive heart failure; active serious infections; liver diseases; renal failure; poorly controlled diabetes; untreated or uncontrolled epileptic seizures; drug abuse; untreated psychiatric disorders
- •20. HIV positive
- •21. Had organ transplant
- •22. Not able to take oral medications
- •23. Females who are pregnant or are breast-feeding
- •24. Concomitant treatment with strong inhibitors or inducers of CYP1A2, CYP3A4 or CYP3A5; or sensitive substrates with narrow therapeutic index (TI) of CYP3A4, CYP2C9 and CYP2C19; or QT prolongating medications within 14 days prior to enrollment and during the study unless there was an emergent or life-threatening medical condition that required it.
- •25. Any medical intervention that will exclude patients based on investigator assessment
研究者
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