Back to results3D1002 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
About this trial
This is an interventional treatment trial for Cancer Pain focused on measuring Cancer pain
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.
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
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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