EUCTR2021-001394-23-FR进行中（未招募）1 期
A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients with Dedifferentiated Liposarcoma
Rain Therapeutics, Inc.0 个研究点目标入组 160 人开始时间: 2021年7月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- 性别
- All
入选标准
- •Each patient must meet all the fowoing criteria:
- •1. Is a male or female patient = 18 years old
- •2. Has a signed and dated informed consent form prior to the start of any study-specific qualification procedures
- •3. Has histologically confirmed DD liposarcoma, with or without a WD component (WD/DD liposarcoma), by local pathologic review; central
- •pathologic review will also be performed but is not required for inclusion.
- •Note: Patient must be willing to provide an archival tumor tissue sample that is = 3 years old and of adequate quality or willing to provide a fresh pretreatment biopsy sample
- •4. Has documented advanced unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) and/or metastatic WD/DD
- •liposarcoma
- •5. Has measurable tumor lesion(s) in accordance with RECIST version 1.1
- •6. Has received 1 or more systemic cancer therapy regimens, including at least 1 anthracycline-based regimen, and had radiographic progressive
- •disease (per RECIST version 1.1) within 6 months before the Screening Visit
- •7. Has resolution of any clinically relevant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy.
- •Note: AEs from prior therapy must resolve to Grade = 1 per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
- •(CTCAE) version 5.0, with the exception of peripheral neuropathy, which must resolve to Grade = 2, and alopecia
- •8. Has an ECOG performance status of 0 or 1
- •9. Has adequate bone marrow function, defined as:
- •o Platelet count = 100 × 109/L
- •o Hemoglobin = 9.0 g/dL
- •o Absolute neutrophil count = 1.5 × 109/L
- •10. Has adequate renal function, defined as creatinine clearance = 30 mL/min, as calculated using the modified Cockcroft-Gault equation
- •11. Has adequate hepatic function, defined as: Alanine aminotransferase and aspartate aminotransferase = 3 × upper limit of normal (ULN) if no liver metastases are present; = 5 × ULN if liver metastases are present
- •o Total bilirubin = 1.5 × ULN. Patients with Gilbert’s disease who have serum bilirubin level = 3x ULN, may be enrolled
- •12. Is willing and able to comply with the protocol requirements.
- •13. Patients requiring anticoagulation medication should be on a stable regimen, defined as at least 4 weeks on the same dose
- •14.Patients requiring antihypertensive medication should be on a stable regimen, defined as at least 4 weeks on the same dose
- •15. If a woman of childbearing potential, has a negative serum pregnancy test at screening and before receiving her first dose of study drug
- •Note: The patient must be willing to use a highly effective contraceptive method as discussed with the Investigator upon randomization through the Treatment Period and until 6 months after the final dose of study drug. A woman is considered to be of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 24 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before randomization or confirmed by testing follicle stimulating hormone levels.
- •16.If a male patient is surgically sterile, willing to use a condom, or remain abstinent upon randomization through the Treatment Period and until 6 months after the final dose of study drug
- •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 Elderl
排除标准
- •A patient who meets any of the following criteria will not be eligible to participate in the study:
- •1-Has received prior treatment with any mouse double minute 2 (MDM2) inhibitor or trabectedin
- •2. Has other primary malignancies that have required systemic cancers that have apparently been cured (e.g., nonmelanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast) and will not interfere with the study outcomes
- •3. Has gastrointestinal conditions that could affect the absorption of milademetan, in the opinion of the Investigator
- •4. Has an uncontrolled infection within the last 7 days requiring IV antibiotics, antivirals, or antifungals
- •5. Has known HIV infection or active hepatitis B or C infection
- •6. Has untreated brain metastases
- •Note: Patients who require steroids for brain metastases must be on a stable or tapering dose of corticosteroids for at least 2 weeks before
- •randomization. If applicable, patients must complete stereotactic radiosurgery 7 days before and whole brain radiotherapy 21 days before
- •their first dose of study drug.
- •7. Has not met the minimum washout period before randomization, defined as:
- •a. Cytochrome P450 3A4 isozyme strong inhibitor: 5 elimination half lives of the inhibitor
- •b. CYP3A strong or moderate inducers (e.g., St. John's wort and modafinil): 4 weeks
- •c. Systemic anticancer therapy (chemotherapy; small molecules, including antibody drug therapy; retinoid therapy; or hormonal therapy) or investigational therapy: 3 weeks or 5 half-lives, whichever is shorter.
- •d. Immunotherapy with checkpoint inhibitor: 4 weeks
- •8. Has had major surgery = 3 weeks from randomization
- •9. Has had curative-intent radiation therapy = 4 weeks or palliative radiation therapy, defined as = 30 Gy in = 10 fractions (e.g., 20 Gy in 5 fractions or 8 Gy in 1 fraction) = 2 weeks from randomization
- •10. Has uncontrolled or significant cardiovascular disease, including:
- •a. QTcF at rest, where the mean QTcF interval is > 480 milliseconds (average of triplicate electrocardiograms [ECGs])
- •b. Myocardial infarction within 6 months prior to screening
- •c. Uncontrolled angina pectoris within 6 months prior to screening
- •d. New York Heart Association Class 3 or 4 congestive heart failure
- •e. Uncontrolled hypertension (resting systolic blood pressure > 180
- •mmHg or diastolic blood pressure > 110 mmHg)
- •11. Is a woman who is pregnant or breastfeeding or intends to become pregnant during the study
- •12. Has a concomitant medical condition that would interfere with the assessment of efficacy or increase the risk of toxicity, in the opinion of the Investigator or Sponsor
研究者
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