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