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
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;
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;
Parallel
VC004 low dose
DrugVC004 low dose BID
VC004 high dose
DrugVC004 high dose BID
VC004 placebo
DrugVC004 placebo BID
Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
