3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain

Официальное название

A Multicenter, Randomized, Phase IIa/IIb Clinical Trial of 3D1002 Combined With Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Patients With Moderate to Severe Cancer Pain

Обзор

This study aims to evaluate the safety and efficacy of 3D1002 alone or in combination with oxycodone hydrochloride sustained-release tablets (OxyContin) for the management of moderate or severe cancer pain.

Подробное описание

The investigational product in this study, 3D1002, is a selective antagonist of prostaglandin E2 receptor subtype 4 (EP4). The study is composed of two stages. Phase IIa stage is to assess the safety and efficacy of 3D1002 administered at doses of 50, 100 or 150 mg every 12 hour (q12h) for patients with moderate to severe cancer pain, and to determine the optimal recommended dose for further studies. Phase IIb stage is to evaluate the difference in the efficacy and safety of 3D1002 combined with OxyContin and OxyContin alone in treatment of patients with moderate to severe cancer pain.

Вмешательства

• Препарат 3D1002 (50 mg)(Phase IIa)
  1 tablet of 3D1002 per oral dose
• Препарат 3D1002 (100 mg)(Phase IIa)
  2 tablets of 3D1002 per oral dose
• Препарат 3D1002 (150 mg)(Phase IIa)
  3 tablets of 3D1002 per oral dose
• Препарат 3D1002 monotherapy (Phase IIb)
  3D1002 is administered at recommended dose with mimic OxyContin tablets.
• Препарат OxyContin monotherapy (Phase IIb)
  OxyContin is administered at an initial dose of 10 mg per dose with mimic 3D1002 tablets.
• Препарат 3D1002 + OxyContin (Phase IIb)
  3D1002 is administered at recommended dose, and OxyContin is administered at an initial dose of 10 mg per dose.

Первичные конечные точки

• Sum of pain intensity difference in the Numeric Rating Scale (NRS) within 14 days after the first study drug treatment (SPID14) [Срок оценки: 1 to 14 days after receiving study treatment]

Вторичные конечные точки (12)

• Proportion of subjects who achieve effective pain control [Срок оценки: 1 to 14 days after receiving study treatment]
• Time to achieve effective pain control [Срок оценки: 1 to 14 days after receiving study treatment]
• Time-specific pain intensity difference（PID） [Срок оценки: 1 to 14 days after receiving study treatment]
• Sum of pain intensity difference (SPID) in the NRS within 3,5 and 7 days post-treatment [Срок оценки: from day 1 to 3, 5 and 7 after receiving study treatment, respectively]
• Time-specific subject self-rated pain relief based on Brief Pain Inventory Short Form (BPI-SF) Questionnaire Item 8 [Срок оценки: 1 to 14 days after receiving study treatment]
• Sum of subject self-rated pain relief based on BPI-SF Questionnaire Item 8 within 3,5,7 and 14 days post-treatment [Срок оценки: from day 1 to 3, 5, 7 and 14 after receiving study treatment, respectively]
• Proportion of subjects with pain response over 7 and 14 days after treatment [Срок оценки: 1 to 14 days after receiving study treatment]
• Time to pain response [Срок оценки: 1 to 14 days after receiving study treatment]
• The number of breakthrough pain episodes and rescue dose of immediate-release oxycodone over 7 and 14 days after treatment; [Срок оценки: 1 to 14 days after receiving study treatment]
• Time-specific oxycodone dose, including immediate-release oxycodone capsules and sustained-release oxycodone tablets (the latter is only applicable for phaseⅡb) [Срок оценки: 1 to 14 days after receiving study treatment]
• Total dose of oxycodone over 3, 7, and 14 days post-treatment [Срок оценки: 1 to 14 days after receiving study treatment]
• Patient's global impression of change (PGI-C) over 7 and 14 days after treatment (for phase IIb only) [Срок оценки: 1 to 14 days after receiving study treatment]

Критерии участия

Критерии включения

• Subject must sign the informed consent in person prior to beginning any screening procedure.
• Age ≥18, both male and female.
• Subjects with a malignant tumor confirmed by histopathology or cytology.
• Weight ≥40 kg at screening period.
• Subjects have relatively stable cancer pain and require continuous analgesic medications (estimated treatment duration ≥2 weeks), as assessed by the investigator.
• Estimated life expectancy ≥3 months.
• Subjects are willing to not use any analgesic other than those specified in the study during the study treatment period.
• ECOG PS score is 0-3.
• Have adequate organ and bone marrow function.
• The mean NRS scores per day during the washout period are ≥4.

Критерии исключения

• Known allergy to any of the active ingredients or excipients of the study drug, or have a history of allergy to other opioids or non-steroidal anti-inflammatory drugs (NSAIDs) and their related ingredients.
• Have a persistent pain resulted from other medical conditions or unknown causes.
• Subjects presenting with emergency symptoms such as intestinal obstruction/perforation, spinal cord compression, epidural metastasis, or fracture.
• Subjects with known active/symptomatic central nervous system metastasis and/or cancerous meningitis.
• Subjects plan to be treated with >10 mg/ day of prednisone or equivalent systemic corticosteroid during the study period.
• Have a history of gastrointestinal bleeding or perforation.
• Have a positive result of fecal occult blood test during screening period.
• Have a history of serious cardiovascular diseases.
• Have a history of an acute ischemic or hemorrhagic stroke within 6 months prior to screening.
• Have a history of significant psychiatric disorders, such as schizophrenia and depression.
• Subjects plan to receive radiotherapy, surgery, or a new regimen of systemic antitumor agents during the study treatment period (D1-D15).
• Subjects have a history of alcohol abuse or drug abuse including opioids.
• Subjects have significant opioid contraindications.
• Pregnant or lactating women.
• Subjects with other diseases that affect the oral administration or absorption of drugs.
• Subjects are currently participating in another clinical study.
• Other conditions deemed by the investigator to be inappropriate for participation in this study, such as poor compliance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05265052 · 3D1002-CN-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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