A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficac… (NCT07731685) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of VC004 Capsules for Pain in Bone Metastases
China26 participantsStarted 2026-07-30
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 is able to communicate well with the investigator, and is willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score
. Female participants who are planning to become pregnant, are pregnant, or are breastfeeding; or participants who are unwilling or unable to use effective contraception throughout the entire study period and for 3 months after the end of the study;
. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.