Lurbinectedin + Doxorubicin In Leiomyosarcoma (NCT05099666) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Lurbinectedin + Doxorubicin In Leiomyosarcoma
United States62 participantsStarted 2022-02-04
Plain-language summary
This research study involves the study drug lurbinectedin in combination with doxorubicin.
This research has two parts. The first part is being done to determine the tolerability of lurbinectedin with doxorubicin in people with soft tissue sarcoma. The second part is a randomized study to determine which is more effective at treating leiomyosarcoma, lurbinectedin with doxorubicin or lurbinectedin alone.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* For Enrollment to Phase 1b: Participants must have histologically confirmed advanced or metastatic soft-tissue sarcoma and no curative multimodality treatment options available.
* For Enrollment to Phase 2: Participants must have histologically confirmed advanced or metastatic leiomyosarcoma (LMS) and no curative multimodality treatment options available.
* Participants must have measurable disease per RECIST 1.1 criteria
* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of lurbinectedin in combination with doxorubicin in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
* ECOG performance status ≤ 2 (Karnofsky ≥ 60%,).
* Participants must have adequate organ and marrow function as defined below:
* Absolute Neutrophil Count ≥ 1,500/mcL
* Hemoglobin (Hgb) ≥ 8 g/dl (transfusion support permitted)
* Platelet Count ≥ 100,000/mcL
* Total Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
* AST (SGOT) / ALT(SGPT) ≤ 2.5 × institutional ULN, OR ≤ 5 × institutional ULN if elevation is a result of metastases
* Creatinine ≤ 1.5 × institutional ULN, OR Creatinine Clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 × institutional normal (calculated via the Cockcroft-Gault equation)
* Creatine Phosphokinase (CPK)\< 2.5 × institutional ULN on two different determinations performed one week (± 1 day) apar…
What they're measuring
1
The maximum tolerated dose (MTD) of lurbinectedin with doxorubicin in participants with advanced soft-tissue sarcoma
Timeframe: 21 Days
2
PFS rate of lurbinectedin with doxorubicin compared to doxorubicin alone in participants with advanced LMS