Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic … (NCT05580588) | Clinical Trial Compass
TerminatedPhase 2
Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas
Stopped: Although no safety issues with SPH4336 were identified, efficacy in liposarcoma patient was less than anticipated.
United States14 participantsStarted 2023-08-31
Plain-language summary
Study SPH4336-US-01 is an open-label (no placebo), multicenter clinical trial to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing the target of the study drug).
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:
* Informed consent
* ≥ 18 years of age
* ECOG performance status 0 or 1
* Histologically confirmed, locally advanced or metastatic sarcoma
* Dedifferentiated or well-differentiated/dedifferentiated liposarcomas
* No more than 3 prior lines of treatment
* Evidence of progression as evidenced by at least one of the following within the past 3 months:
* An increase of at least 20% in measurable tumors
* The appearance of new lesions
* Unequivocal progression of non-measurable lesions
* Measurable disease per RECIST v1.1
* If residual treatment-related toxicity from prior therapy:
* All treatment-related toxicity resolved to Grade 1 or baseline (alopecia excepted)
* ANC ≥ 1,500/μL
* Platelets ≥ 100,000/μL
* Hgb ≥ 9.0 g/dL (in the absence of pRBC transfusion over the prior 4 weeks)
* Estimated glomerular filtration rate of ≥ 60 mL/min (based on the Cockcroft and Gault formula for individualized estimates of GFR)
* Total bilirubin ≤ 1.5 x the Upper Limit of Normal (ULN) or ≤ 3 x ULN if known Gilbert's disease
* AST and ALT ≤ 3 x ULN or ≤ 5 x ULN if malignant involvement of the liver
* Sterile or willing to use effective contraception (approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings or hormonally-impregnated intrauterine device (IUD), or an IUD in women of childbearing potential and a condom in men) during the study and for 3 months following the last dose of study drug
* Availability of archived tum…
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.