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
This is a phase 2, open-label, non-randomized, single institution study investigating the novel glycogen synthase kinase-3 beta (GSK-3β) inhibitor 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC). The U.S. Food and Drug Administration (FDA) has not approved 9-ING-41 as a treatment for any disease. Carboplatin is used as a treatment for salivary gland cancers, and is approved by the FDA for many cancer types. 9-ING-41 has been identified in other studies as a therapy to block the over-expression of the glycogen synthase kinase-3 beta (GSK-3β) protein, which is thought to be important in signaling cancer growth and to have immune properties. It is believed that GSK-3β is over-expressed in salivary gland cancers and by blocking the action of GSK-3β protein with 9-ING-41 it could slow salivary cancer cell growth that have developed resistance to prior chemotherapy exposure. The research study procedures include screening for eligibility and study treatment including evaluations and follow-up visits roughly every 3-weeks while on therapy, for up to one year as long as disease does not get worse and the drug therapy remains safe and tolerable. It is expected that about 33 people treated will take part in this research study. Actuate Therapeutics is supporting this research study by providing the study drug (9-ING-41) and funding some of the logistics of the trial that are beyond what would be considered standard of care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Intravenous infusion
Intravenous infusion
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Best Overall response rate
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Measured with RECIST v 1.1
Time frame: Up to 1 year
Progression Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
Time frame: Up to 1 year
Overall Survival (OS)
Overall Survival (OS) is defined as the time from study registration to death due to any cause, or censored at date last known alive
Time frame: Up to 2 years
Duration of therapeutic response
Assessed using RECIST v1.1
Time frame: Up to 2 years
Duration of therapeutic response Cohort 1
Assessed using RECIST v1.1
Time frame: Up to 2 years
Duration of therapeutic response Cohort 2
Assessed using RECIST v1.1
Time frame: Up to 2 years
Number of Participants with treatment related Adverse Events per CTCAE 5.0
Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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Time frame: Up to 2 years
University of Washington Quality of Life Questionnaire (UW-QOL) Response
Descriptive statistics from the questionnaire will be summarized across timepoints of assessment. Rates of drop-out/non-response to QOL assessments and corresponding reason will also be summarized across timepoints of assessment.
Time frame: Baseline, 12 weeks up to 1 year