9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma (NCT05010629) | Clinical Trial Compass
Active — Not RecruitingPhase 2
9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma
United States35 participantsStarted 2021-09-14
Plain-language summary
This trial is investigating an intravenous (IV) medication called 9-ING-41 in combination with chemotherapy (carboplatin) for the treatment of advanced salivary gland cancers.
The names of the study drug(s) involved in this study are:
* 9-ING-41 (a GSK-3β inhibitor)
* Carboplatin chemotherapy
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically confirmed salivary gland carcinoma (any histologic subtype, including ACC) with evidence of recurrent, metastatic or advanced, unresectable disease.
* Willing to provide tumor tissue from a diagnostic biopsy or prior surgery.
* Age 18 years or older
* ECOG performance status 0-2 (see Appendix A)
* Participant must have organ and marrow function as defined below within 14 days prior to study registration:
* leukocytes ≥ 3,000/mcL
* absolute neutrophil count ≥ 500/mcL
* hemoglobin ≥ 8.5 g/dL
* platelets ≥ 75,000/mcL
* total bilirubin ≤ 2.0 g/dL
* AST(SGOT)/ALT(SGPT) ≤ 2.5× institutional upper limit of normal
* creatinine within normal institutional limits OR
* creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
* Participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within 12 months prior to study registration (progression of disease over any interval is allowed) and/or new or worsening disease-related symptoms within 12 months prior to study registration. This assessment is performed by the treating investigator. Evidence of progression by RECIST v1.1 criteria not required.
* Participants must have at least one RECIST v1.1 measurable non-CNS based lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal l…