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Tests treatment safety and results for PIK3CA-Related Overgrowth Spectrum (PROS)
Official title Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Patients With PIK3CA-related Overgrowth Spectrum (PROS) and PIK3CA-related Vascular Malformations (PRVM)
ClinicalTrials.gov ID: NCT06975618
What this study is testing
What is CYH33?
CYH33 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pik3ca-related overgrowth spectrum (pros).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multi-center, open-label, single arm, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 in patients with PIK3CA-related overgrowth spectrum (PROS) and PIK3CA-related vascular malformations (PRVM)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- The patient or the patient's legal guardian (if applicable) voluntarily signs the Informed Consent Form.
- At the time of signing the informed consent, adult patients should be ≥18 years old (or meet the legal adult age according to local regulations), and...
- The patient is diagnosed with PIK3CA-related overgrowth spectrum (PROS) or PIK3CA-related vascular malformations (PRVM), and provides a report...
- Patients should demonstrate adequate organ and bone marrow function during the 28-day screening period. Key
You likely can't join if
- PROS patients presenting solely with isolated macrodactyly, epidermal nevi/nevus, and megalencephaly (only one clinical feature or any combination of...
- Patients who have received any systemic treatment for PROS or PRVM within 8 weeks prior to the first dose of study drug, or any drug treatment for...
- Patients who have previously received any PI3K inhibitor treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Sapporo, Hokkaido, Japan
- Kobe, Hyōgo, Japan
- Yokohama, Kanagawa, Japan
- Sendai, Miyagi, Japan
- Matsumoto, Nagano, Japan
- Mitaka, Tokyo, Japan
- Gifu, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Changsha, Hunan, China; Shanghai, Shanghai Municipality, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.