Active — Not RecruitingPhase 2

Palbociclib and INCMGA00012 in People With Advanced Liposarcoma

United States42 participantsStarted 2020-06-17

Plain-language summary

The researchers are doing this study to find out whether combining the study drugs palbociclib and INCMGA00012 is an effective and safe treatment for advanced liposarcoma. "Funding Source - FDA OOPD"

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Absolute neutrophil count ≥ 1.5 x 109/L
✓. Hemoglobin ≥ 8.0 g/dL
✓. WBC ≥ 3.0 x 109/L
✓. Platelets ≥ 100 x 109/L
✓. ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN)
✓. AST (SGOT) /ALT (SGPT) ≤ 3 x institutional ULN
✓. Creatinine Clearance \> 30 mL/min (calculated by Cockcroft-Gault method)

Exclusion criteria

✕. Patients with a CD4+ count of \> 300 and an undetectable viral load who are currently on HAART are eligible for inclusion
✕. Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded

What they're measuring

confirm the recommended phase two dose (RP2D

Timeframe: within 6 weeks of treatment

best overall response rate (Phase II)

Timeframe: by 48 weeks

Trial details

NCT IDNCT04438824

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Well-differentiated/Dedifferentiated Liposarcoma trials