ACTRN12620000182998尚未招募1 期
Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Doses of DB-020 in Patients Receiving Cisplatin
Decibel Therapeutics Australia Pty Ltd0 个研究点目标入组 70 人开始时间: 2020年2月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Ability to communicate with medical team and staff, willingness to participate in the study, willingness to give written informed consent, and willingness to comply with the study restrictions.
- •2. Adults aged 18 to 75 years, inclusive, at the time of signing the informed consent form.
- •3. Patients with cancer for whom treatment with IV cisplatin once every 21 or 28 days is indicated must meet all of the following criteria.
- •a. Plan to receive a minimum cumulative dose of cisplatin of greater than or equal to 280 mg/m2 over at least three cycles (21-day or 28-day cycles) for treatment of cancer of any type.
- •b. Concomitant use of other chemotherapy and radiation is permitted except investigational agents and/or radiation > 35 Gy involving the cochlear area
- •4. Male patients, their female partner(s), and female patients of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last study drug administration. Acceptable barrier forms of contraception are condom and diaphragm. Acceptable forms of contraception for this study for female partner(s) of childbearing potential and premenopausal female patients are nonhormonal and hormonal intrauterine device (IUD), hormonal birth control pills, hormonal birth control patches, hormonal birth control injections (eg, Depo-Provera®), hormonal birth control implants, NuvaRing®, and/or spermicide. Male and female patients who consider themselves abstinent, and who agree to remain abstinent during the study and for 90 days after the last study drug administration, will be eligible to participate in the study.
- •Women of nonchildbearing potential are eligible for the study and are defined as 12 months with no menses prior to screening and a serum FSH >40 IU/L at Screening (ie, postmenopausal female patients), or surgically sterile female patients, eg, those having undergone total abdominal hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to screening for study participation. Surgically sterile female patients may participate if they agree to use condoms with spermicide during the study and for
- •90 days after the last study drug administration.
- •Men who have undergone a vasectomy at least 6 months prior to Screening and who have a documented negative sperm count (eg, medical records or single semen specimen) after the procedure are not required to use contraception.
- •Male patients must agree to refrain from sperm donation within 90 days after the last study drug administration.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- •6. Anticipated survival > 1 year.
- •7. Normal or not clinically significant otoscopic findings in both ears.
- •8. Patient has read, understood, and voluntarily signed the informed consent form.
排除标准
- •1. Female or male patients with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after last dose of study drug.
- •2. Prior treatment with a cisplatin regimen.
- •3. Signs of disturbed integrity of the tympanic membrane on otoscopy or tympanometry.
- •4. History of congenital hearing loss, ontological surgery (excluding myringotomy tubes or simple tympanoplasty), sudden hearing loss, conductive hearing loss > 10 dB at 2 frequencies in either ear, Meniere’s disease, or autoimmune middle ear disease.
- •5. Hearing loss greater than (not including) 35 dB HL averaged at 6 and 8 kHz in either ear.
- •6. Asymmetry in hearing thresholds between left and right ear equal to or exceeding 20 dB at any single frequency or 10 dB at any 3 consecutive frequencies, up to and including 8 kHz.
- •7. Previous radiation exposure > 35 Gy to all or part of the cochlea.
- •8. Consumption of > 6 g of salicylate or > 5 g of acetaminophen (paracetamol) per day for the past month, or aminoglycoside use in the past month
- •9. Use of any investigational drug or device within 30 days prior to the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, if known, whichever time is longer.
- •10. History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) and/or allergy
- •to the excipients of the study medications.
- •11. Presence of hepatitis C antibody with reflex hepatitis C virus (HCV) RNA testing (if anti-HCV is positive), hepatitis B surface antigen, or HIV antibodies 1 and 2.
- •12. History or presence of malignancy within the past 5 years other than a history of localized or surgical removal of focal basal cell skin cancer; cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy) or by hysterectomy, or malignancy for which the patient is receiving cisplatin therapy.
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