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 range18 Years
SexALL
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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…