NL-OMON56391招募中不适用
A phase 1 study of oral Debio 0123 in combination with carboplatin in patients with advanced solid tumors. - Phase I dose-finding study of Debio 0123 in combination with carboplatin.
Debiopharm0 个研究点目标入组 81 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 81
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
- •Dose escalation part:
- •1.Histologically or cytologically confirmed locally advanced or metastatic
- •solid and non-bleeding tumors that had recurred or progressed following
- •standard therapy, has not responded to standard therapy or for which no
- •standard therapy of proven benefit is available.
- •2. In addition, for Arm B of the dose escalation part only: The subject should
- •be willing to comply with the requirements for the food effect high gastric pH
- •(lansoprazole) investigations and have no contraindications to these
- •requirements.
- •Expansion part:
- •1. Platinum-resistant, recurrent, histologically or cytologically confirm high
- •grade (serious, clear cell, or endometrioid) EOC, primary peritoneal cancer, or
- •fallopian tube cancer.
- •2. Measurable disease per RECIST version 1.1.
- •3. Documented progressive or recurrent disease according to RECIST version 1.1
- •since the last anti-cancer therapy and prior to study entry.
- •Patients with CA-125 progression in the absence of measurable disease will NOT
- •be eligible.
- •Both dose escalation and Expansion:
- •1.Able and willing to undergo tumor biopsy unless archived tumor sample is
- •2.Previous platinum-based chemotherapy (carboplatin or cisplatin).
- •3.Life expectancy of at least 3 months in the best judgement of the
- •Investigator.
- •4.Adequate bone marrow, liver biochemistry, renal function and adequate
- •coagulation status
- •5.Female subjects of child-bearing potential must have a negative serum
- •pregnancy test at screening and be willing to practice the following highly
- •effective contraception methods from the time of study entry up to 6 months
- •after the last day of treatment:
- •Male subjects must agree to use a condom from study entry and up to 6 months
- •after the last day of treatment. The subject's female partner should use highly
- •effective contraception methods, which may include oral contraceptives or any
- •of the methods outlined above, during this period.
排除标准
- •1.History of other malignancies requiring active treatment in the last 6 months.
- •2.Brain tumors and/or brain metastases unless they are asymptomatic, stable on
- •recent imaging (not dated more than 30 days from the inclusion date) and have
- •not required active treatment in the last 3 months.
- •3.History of myocardial infarction or stroke within 6 months, congestive heart
- •failure greater than New York Heart Association (NYHA) class II, unstable
- •angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring
- •treatment or family history of sudden death from cardiac-related causes before
- •the age of 50, any cardiotoxicity experienced after previous chemotherapy.
- •4. Left ventricular ejection fraction (LVEF) below the normal range (< 55%)
- •5.Baseline Fridericia's corrected QT (QTcF) interval greater than 470 ms
- •(female) or greater than 450 ms (male), history of congenital long QT syndrome,
- •the presence in the screening ECG of a conduction abnormality that in the
- •opinion of the Investigator would preclude safe participation in this study.
- •6.Concomitant use of a drug with a known risk of QTc. If such a drug has been
- •used by the subject, a wash-out period of at least 5 half-lives of the drug
- •must occur before the first administration of study treatment.
- •7. Concomitant use of a drug or herbal product that is an inhibitor or inducer
- •of CYP3A4, orr concomitant use of any drug(s) on the prohibited medication list
- •(provided in Section 6.5.3). If such a drug has been used by the subject, a
- •wash-out period of at least 5 half-lives of the drug must occur before the
- •first administration of study treatment. For irreversible CYP inhibitors and
- •CYP inducers, a 4-week wash-out period must be applied.
- •8.Known infection requiring the systemic use of, for example, an antibiotic or
- •antiviral agent.
- •9.Pregnant or lactating woman with positive pregnancy test result
- •10.Chemotherapy, monoclonal antibodies/biologics, radiotherapy with curative
- •intent or coronavirus disease-19 (COVID-19) vaccine within 28 days prior to
- •starting study treatment. Treatment can start earlier if toxicities from
- •previous treatment(s) are reduced to grade 1, and the investigator judges that
- •treatment cannot wait. Palliative radiation for pain relief is allowed up to
- •one week prior to study treatment start.
- •11.Not recovered from AEs (>grade 1) or toxicities due to previous treatments
- •12.Hypersensitivity to carboplatin or any of the excipients
- •13. Subjects who are exposed to high levels of ultraviolet (UV) light, for
- •example occupational exposure to sunlight or sun bathing
- •14. Immunization with live or live-attenuated vaccine within 28 days prior to
- •study inclusion or planned injection of live or live-attenuated vaccine.
- •15. For dose escalation Arm B only, hypersensitivity to lansoprazole or any of
- •the excipients
研究者
相似试验
终止
1 期
Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid TumorsAdvanced Solid TumorsNCT03968653Debiopharm International SA76
招募中
1 期
A Study of Debio 0123 in Combination with Temozolomide in Adult Participants with Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination with Temozolomide and Radiotherapy in Adult Participants with Newly Diagnosed GlioblastomaMedDRA version: 20.0Level: PTClassification code: 10018336Term: Glioblastoma Class: 100000004864GlioblastomaCTIS2022-502156-31-00Debiopharm International S.A.48
终止
1 期
A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid TumorsAdvanced Solid TumorsNCT05109975Debiopharm International SA93
招募中
1 期
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic ImpairmentMyelodysplastic SyndromesAcute Myeloid LeukemiaNCT04953910Taiho Oncology, Inc.27
招募中
1 期
A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed GlioblastomaGlioblastoma IDH (Isocitrate Dehydrogenase) WildtypeAstrocytoma, Grade IIINCT05765812Debiopharm International SA116