A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of VC004 Capsules for Pain in Bone Metastases

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu vcare pharmaceutical technology co., LTD

About this trial

This is a randomized, double-blind, placebo-controlled Phase Ib study evaluating the safety and efficacy of VC004 capsules for the relief of moderate-to-severe pain associated with bone metastases

Eligibility criteria

Qualifiers

Participants must understand and voluntarily sign the informed consent form (ICF);

Male or female, aged ≥ 18 years;

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;

Life expectancy of ≥ 12 weeks, as assessed by the investigator;

Disqualifiers

The participant's pain is associated with oncologic emergencies, such as intestinal obstruction/perforation, spinal cord compression, epidural metastasis, or fracture or impending fracture of weight-bearing bones;

The participant has known or suspected unstable brain metastases or leptomeningeal metastases;

History of severe alcohol, analgesic, or narcotic drug abuse within 6 months prior to screening;

Major surgery within 3 months prior to screening, or planned major surgery during the study period;

Trial design

Treatments tested in this trial

  • VC004 low dose
  • VC004 high dose
  • VC004 placebo

Treatment groups

26 Participants
are divided into 3 treatment groups