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 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:
* 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…
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.