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

Primary Purpose

Cancer Pain

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
3D1002 (50 mg)(Phase IIa)
3D1002 (100 mg)(Phase IIa)
3D1002 (150 mg)(Phase IIa)
3D1002 monotherapy (Phase IIb)
OxyContin monotherapy (Phase IIb)
3D1002 + OxyContin (Phase IIb)
Sponsored by
3D Medicines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pain focused on measuring Cancer pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Have a persistent pain resulted from other medical conditions or unknown causes.
  3. Subjects presenting with emergency symptoms such as intestinal obstruction/perforation, spinal cord compression, epidural metastasis, or fracture.
  4. Subjects with known active/symptomatic central nervous system metastasis and/or cancerous meningitis.
  5. Subjects plan to be treated with >10 mg/ day of prednisone or equivalent systemic corticosteroid during the study period.
  6. Have a history of gastrointestinal bleeding or perforation.
  7. Have a positive result of fecal occult blood test during screening period.
  8. Have a history of serious cardiovascular diseases.
  9. Have a history of an acute ischemic or hemorrhagic stroke within 6 months prior to screening.
  10. Have a history of significant psychiatric disorders, such as schizophrenia and depression.
  11. Subjects plan to receive radiotherapy, surgery, or a new regimen of systemic antitumor agents during the study treatment period (D1-D15).
  12. Subjects have a history of alcohol abuse or drug abuse including opioids.
  13. Subjects have significant opioid contraindications.
  14. Pregnant or lactating women.
  15. Subjects with other diseases that affect the oral administration or absorption of drugs.
  16. Subjects are currently participating in another clinical study.
  17. Other conditions deemed by the investigator to be inappropriate for participation in this study, such as poor compliance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    3D1002 50 mg group (Phase IIa)

    3D1002 100 mg group (Phase IIa)

    3D1002 150 mg group (Phase IIa)

    3D1002 monotherapy group (Phase IIb)

    OxyContin monotherapy group (Phase IIb)

    3D1002 + OxyContin group (Phase IIb)

    Arm Description

    3D1002 is given 50 mg twice a day for 2 weeks.

    3D1002 is given 100 mg twice a day for 2 weeks.

    3D1002 is given 150 mg twice a day for 2 weeks.

    3D1002 at recommended dose plus mimic OxyContin tables, will be given twice a day for 2 weeks.

    OxyContin initiating at 10mg per dose plus mimic 3D1002 tablets, will be given twice a day for 2 weeks.

    3D1002 at recommended dose plus OxyContin initiating at 10 mg per dose, will be given twice a day for 2 weeks.

    Outcomes

    Primary Outcome Measures

    Sum of pain intensity difference in the Numeric Rating Scale (NRS) within 14 days after the first study drug treatment (SPID14)
    ①Average pain intensity is calculated daily for the past 24 hours using the NRS (0 = No pain, 10 = Worst pain imaginable). ②PID (pain intensity difference): Baseline pain intensity score (for the day prior to the day of randomization) minus pain intensity score at each given day.③SPID: the sum of the pain intensity difference generated daily from day 1 to the designated day.

    Secondary Outcome Measures

    Proportion of subjects who achieve effective pain control
    Effective pain control: mean NRS score within 0-3 points and episode of breakthrough pain ≤ 2 times in 24 hours
    Time to achieve effective pain control
    Time-specific pain intensity difference(PID)
    Sum of pain intensity difference (SPID) in the NRS within 3,5 and 7 days post-treatment
    Time-specific subject self-rated pain relief based on Brief Pain Inventory Short Form (BPI-SF) Questionnaire Item 8
    The pain relief is assessed daily for the past 24 hours based on the percentage of relief from baseline, ranging from 0 (no relief) to 100% (complete relief).
    Sum of subject self-rated pain relief based on BPI-SF Questionnaire Item 8 within 3,5,7 and 14 days post-treatment
    Proportion of subjects with pain response over 7 and 14 days after treatment
    Pain response: at least 30% and 50% decrease in pain intensity NRS score from baseline.
    Time to pain response
    The number of breakthrough pain episodes and rescue dose of immediate-release oxycodone over 7 and 14 days after treatment;
    Time-specific oxycodone dose, including immediate-release oxycodone capsules and sustained-release oxycodone tablets (the latter is only applicable for phaseⅡb)
    Total dose of oxycodone over 3, 7, and 14 days post-treatment
    Evaluation of the subjects' quality of life over 7 and 14 days after treatment by using of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 V3.0) (for phase Ⅱb only)
    EORTC QLQ-C30 comprises 30 items, including five functioning scales, a global quality of life (QoL) scale, three symptom scales and six single items. For the functioning and the global QoL scales, a higher score denotes better health. For the symptom scales and single-item scales, a higher score indicates more symptom burden.
    Patient's global impression of change (PGI-C) over 7 and 14 days after treatment (for phase IIb only)
    PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale, with 1 being "very much improved" and 7 being "very much worse".
    Frequency and severity of adverse events during treatment

    Full Information

    First Posted
    January 24, 2022
    Last Updated
    October 24, 2023
    Sponsor
    3D Medicines
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05265052
    Brief Title
    3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2024 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    3D Medicines

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Pain
    Keywords
    Cancer pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Both phase IIa and IIb are randomized, parallel controlled studies.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    177 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    3D1002 50 mg group (Phase IIa)
    Arm Type
    Experimental
    Arm Description
    3D1002 is given 50 mg twice a day for 2 weeks.
    Arm Title
    3D1002 100 mg group (Phase IIa)
    Arm Type
    Experimental
    Arm Description
    3D1002 is given 100 mg twice a day for 2 weeks.
    Arm Title
    3D1002 150 mg group (Phase IIa)
    Arm Type
    Experimental
    Arm Description
    3D1002 is given 150 mg twice a day for 2 weeks.
    Arm Title
    3D1002 monotherapy group (Phase IIb)
    Arm Type
    Experimental
    Arm Description
    3D1002 at recommended dose plus mimic OxyContin tables, will be given twice a day for 2 weeks.
    Arm Title
    OxyContin monotherapy group (Phase IIb)
    Arm Type
    Experimental
    Arm Description
    OxyContin initiating at 10mg per dose plus mimic 3D1002 tablets, will be given twice a day for 2 weeks.
    Arm Title
    3D1002 + OxyContin group (Phase IIb)
    Arm Type
    Experimental
    Arm Description
    3D1002 at recommended dose plus OxyContin initiating at 10 mg per dose, will be given twice a day for 2 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    3D1002 (50 mg)(Phase IIa)
    Intervention Description
    1 tablet of 3D1002 per oral dose
    Intervention Type
    Drug
    Intervention Name(s)
    3D1002 (100 mg)(Phase IIa)
    Intervention Description
    2 tablets of 3D1002 per oral dose
    Intervention Type
    Drug
    Intervention Name(s)
    3D1002 (150 mg)(Phase IIa)
    Intervention Description
    3 tablets of 3D1002 per oral dose
    Intervention Type
    Drug
    Intervention Name(s)
    3D1002 monotherapy (Phase IIb)
    Intervention Description
    3D1002 is administered at recommended dose with mimic OxyContin tablets.
    Intervention Type
    Drug
    Intervention Name(s)
    OxyContin monotherapy (Phase IIb)
    Intervention Description
    OxyContin is administered at an initial dose of 10 mg per dose with mimic 3D1002 tablets.
    Intervention Type
    Drug
    Intervention Name(s)
    3D1002 + OxyContin (Phase IIb)
    Intervention Description
    3D1002 is administered at recommended dose, and OxyContin is administered at an initial dose of 10 mg per dose.
    Primary Outcome Measure Information:
    Title
    Sum of pain intensity difference in the Numeric Rating Scale (NRS) within 14 days after the first study drug treatment (SPID14)
    Description
    ①Average pain intensity is calculated daily for the past 24 hours using the NRS (0 = No pain, 10 = Worst pain imaginable). ②PID (pain intensity difference): Baseline pain intensity score (for the day prior to the day of randomization) minus pain intensity score at each given day.③SPID: the sum of the pain intensity difference generated daily from day 1 to the designated day.
    Time Frame
    1 to 14 days after receiving study treatment
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects who achieve effective pain control
    Description
    Effective pain control: mean NRS score within 0-3 points and episode of breakthrough pain ≤ 2 times in 24 hours
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Time to achieve effective pain control
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Time-specific pain intensity difference(PID)
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Sum of pain intensity difference (SPID) in the NRS within 3,5 and 7 days post-treatment
    Time Frame
    from day 1 to 3, 5 and 7 after receiving study treatment, respectively
    Title
    Time-specific subject self-rated pain relief based on Brief Pain Inventory Short Form (BPI-SF) Questionnaire Item 8
    Description
    The pain relief is assessed daily for the past 24 hours based on the percentage of relief from baseline, ranging from 0 (no relief) to 100% (complete relief).
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Sum of subject self-rated pain relief based on BPI-SF Questionnaire Item 8 within 3,5,7 and 14 days post-treatment
    Time Frame
    from day 1 to 3, 5, 7 and 14 after receiving study treatment, respectively
    Title
    Proportion of subjects with pain response over 7 and 14 days after treatment
    Description
    Pain response: at least 30% and 50% decrease in pain intensity NRS score from baseline.
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Time to pain response
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    The number of breakthrough pain episodes and rescue dose of immediate-release oxycodone over 7 and 14 days after treatment;
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Time-specific oxycodone dose, including immediate-release oxycodone capsules and sustained-release oxycodone tablets (the latter is only applicable for phaseⅡb)
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Total dose of oxycodone over 3, 7, and 14 days post-treatment
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Evaluation of the subjects' quality of life over 7 and 14 days after treatment by using of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 V3.0) (for phase Ⅱb only)
    Description
    EORTC QLQ-C30 comprises 30 items, including five functioning scales, a global quality of life (QoL) scale, three symptom scales and six single items. For the functioning and the global QoL scales, a higher score denotes better health. For the symptom scales and single-item scales, a higher score indicates more symptom burden.
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Patient's global impression of change (PGI-C) over 7 and 14 days after treatment (for phase IIb only)
    Description
    PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale, with 1 being "very much improved" and 7 being "very much worse".
    Time Frame
    1 to 14 days after receiving study treatment
    Title
    Frequency and severity of adverse events during treatment
    Time Frame
    1 to 14 days after receiving study treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qiling Huang
    Phone
    18312677976
    Email
    qiling.huang@3d-medicines.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suxia Luo
    Organizational Affiliation
    Henan Cancer Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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