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

NCT05265052 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 3D1002-CN-001
• Study Type: interventional
• Target: 177
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer Pain

Keywords

Cancer pain

Outcome Measures

Primary Outcomes (1)

• 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.

  1 to 14 days after receiving study treatment

Secondary Outcomes (13)

• Proportion of subjects who achieve effective pain control

  1 to 14 days after receiving study treatment

• Time to achieve effective pain control

  1 to 14 days after receiving study treatment

• Time-specific pain intensity difference（PID）

  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

  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

  1 to 14 days after receiving study treatment

Study Arms (6)

3D1002 50 mg group (Phase IIa)

EXPERIMENTAL

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

Drug: 3D1002 (50 mg)(Phase IIa)

3D1002 100 mg group (Phase IIa)

EXPERIMENTAL

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

Drug: 3D1002 (100 mg)(Phase IIa)

3D1002 150 mg group (Phase IIa)

EXPERIMENTAL

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

Drug: 3D1002 (150 mg)(Phase IIa)

3D1002 monotherapy group (Phase IIb)

EXPERIMENTAL

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

Drug: 3D1002 monotherapy (Phase IIb)

OxyContin monotherapy group (Phase IIb)

EXPERIMENTAL

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

Drug: OxyContin monotherapy (Phase IIb)

3D1002 + OxyContin group (Phase IIb)

EXPERIMENTAL

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

Drug: 3D1002 + OxyContin (Phase IIb)

Interventions

3D1002 (50 mg)(Phase IIa) DRUG

1 tablet of 3D1002 per oral dose

3D1002 50 mg group (Phase IIa)

3D1002 (100 mg)(Phase IIa) DRUG

2 tablets of 3D1002 per oral dose

3D1002 100 mg group (Phase IIa)

3D1002 (150 mg)(Phase IIa) DRUG

3 tablets of 3D1002 per oral dose

3D1002 150 mg group (Phase IIa)

3D1002 monotherapy (Phase IIb) DRUG

3D1002 is administered at recommended dose with mimic OxyContin tablets.

3D1002 monotherapy group (Phase IIb)

OxyContin monotherapy (Phase IIb) DRUG

OxyContin is administered at an initial dose of 10 mg per dose with mimic 3D1002 tablets.

OxyContin monotherapy group (Phase IIb)

3D1002 + OxyContin (Phase IIb) DRUG

3D1002 is administered at recommended dose, and OxyContin is administered at an initial dose of 10 mg per dose.

3D1002 + OxyContin group (Phase IIb)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 3D Medicines: lead

MeSH Terms

Conditions

Cancer Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Suxia Luo

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiling Huang

CONTACT

18312677976; qiling.huang@3d-medicines.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Both phase IIa and IIb are randomized, parallel controlled studies.

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 3, 2022
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share