NL-OMON50797撤回2 期
Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients with Advanced Solid Tumors - Phase * study with tinostamustine in pat. with advanced solid tumors
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mundipharma
- 入组人数
- 15
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •General Inclusion Criteria:
- •Signed informed consent.
- •Patients age >=18 years at signing of the informed consent.
- •Life expectancy > 3 months
- •Histologically confirmed diagnosis of advanced or metastatic solid
- •tumors, disease should have progressed following at least 1 line of therapy and
- •no other standard therapy with proven clinical benefit is available or
- •recommended based on the investigator*s individual risk- benefit assessment for
- •the patient.
- •Patients with secondary metastasis to the central nervous system
- •(CNS) are eligible if they have had brain metastases resected or have received
- •radiation therapy ending at least 4 weeks prior to trial day 1 and they meet
- •all of the following criteria:
- •(1) Residual neurological symptoms <= Grade 1
- •(2) No glucocorticoids requirement or patients may be receiving low doses of
- •glucocorticoids providing the dose has been stable for at least 2 weeks prior
- •to starting the trial medication
- •(3) Follow-up imaging studies show no progression of treated lesions and no new
- •Evaluable disease; either measurable on imaging or with informative tumor
- •marker as assessed by RECIST version 1.1.
- •Eastern Cooperative Oncology Group (ECOG) performance status <=2
- •(Section 13.1).
- •Absolute neutrophil count (ANC) (polymorphonuclear [PMN] cells plus bands)
- •>1,000 µL.
- •Platelets >=100,000 / µL. Platelet transfusions within the 14 days before
- •Day 1 of Cycle 1 is
- •prohibited.
- •Aspartate aminotransferase/alanine aminotransferase (AST/ALT) <=3×
- •upper limit of normal (ULN). In cases with liver involvement ALT/ AST
- •<=5× ULN.
- •Total bilirubin <=1.5 mg/dL unless elevated due to known Gilbert*s
- •Creatinine <=1.5 ULN.
- •Serum potassium and magnesium at least at above the lowest limit of normal
- •(LLN) range, before every IMP administration. If it is below LLN,
- •supplementation is permissible.
- •Female study participants of child-bearing potential and their partners, and
- •male study participants who intend to be sexually active with a woman of
- •child-bearing potential, must be willing to use at least TWO highly effective
- •forms of contraception
- •Female study participants of child-bearing potential must continue using
- •contraception for at least six months after the last administration of the IMP.
- •Male study participants who are sexually active with a woman of child-bearing
- •potential should also use a condom during treatment and for at least ninety
- •(90) days after the last administration of IMP.
- •Cohort-specific eligibility criteria phase 2 portion of the trial in addition
- •to the general inclusion/exclusion criteria for listed above (refer to
- •protocol page 19-21).
- •Cohort 1 Patient Population: Relapsed/Refractory Small-cell Lung Cancer (SCLC)
- •Cohort 2 Patient Population: Relapsed/Refractory Soft Tissue Sarcoma
- •Cohort 3 Patient Population: Relapsed/Refractory Triple Negative Breast Cancer
- 另有 4 项未显示
排除标准
- •To be eligible to participate in the trial, a patient cannot meet any of the
- •following exclusion criteria:
- •Patients with primary CNS cancer.
- •Patients with QTc interval (Fridericia*s formula) >450 ms.
- •Patients who are on treatment with drugs known to prolong the QT/QTc
- •interval. Refer to CredibleMeds list of drugs with known risk of Torsade des
- •pointes (TdP): http://crediblemeds.org/new-drug-list.
- •Patients who are being treated with valproic acid for any of its indication
- •(epilepsy, mood disorder)
- •Any serious medical condition that interferes with adherence to trial
- •procedures.
- •Prior history of another solid tumor malignancy diagnosed within the last 3
- •years of trial enrollment excluding adequately treated basal cell carcinoma of
- •the skin, squamous cell carcinoma of the skin, or in situ cervical cancer, in
- •situ breast cancer, in situ prostate cancer (patients must have shown no
- •evidence of active disease for 2 years prior to enrollment).
- •Pregnant or breast feeding women.
- •New York Heart Association (NYHA) stage III/IV congestive heart failure
- •(Section 13.2). The following arrhythmias: atrial fibrillation/flutter with
- •poor rate control, documented sustained ventricular tachycardia (defined
- •as >30 seconds or requiring cardioversion before
- •30 seconds have elapsed) or TdP.
- •Significant co-morbidities (e.g., active infection requiring systemic
- •therapy, history of human immunodeficiency virus [HIV] infection, or active
- •Hepatitis B or Hepatitis C).
- •Use of other investigational agents or previous anticancer therapies
- •within 28 days prior to the first dose of tinostamustine, provided the patient
- •has recovered from any related toxicities >=Grade 1.
- •Steroid treatment within 7 days prior to trial treatment. Patients that
- •require intermittent use of bronchodilators, topical steroids, or local steroid
- •injections will not be excluded from the trial. Patients who have been
- •stabilized to 10 mg prednisolone orally (PO) once daily (QD) (or equivalent),
- •daily (or less) at least 7 days prior to trial drug administration are allowed.
- •Cohort-specific eligibility criteria phase 2 portion of the trial in addition
- •to the general inclusion/exclusion criteria for listed above (refer to
- •protocol page 19-21).
- •Cohort 1 Patient Population: Relapsed/Refractory Small-cell Lung Cancer (SCLC)
- •Cohort 2 Patient Population: Relapsed/Refractory Soft Tissue Sarcoma
- •Cohort 3 Patient Population: Relapsed/Refractory Triple Negative Breast Cancer
- •(RECRUITMENT INTO THIS COHORT HAS NOW BEEN HALTED)
- •Cohort 4 Patient Population: Relapsed/Refractory Ovarian Cancer
- •Cohort 5 Patient Population: Relapsed/Refractory Endometrial Cancer
- •(RECRUITMENT INTO THIS COHORT HAS NOW BEEN HALTED)
研究者
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