MedTrace Logo

9-ING-41 Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma

NCT04832438 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-02-22

No results posted yet for this study

Summary

9-ING-41 is a small molecule potent selective GSK-3β inhibitor with antitumor activity. This study investigates 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC). Patients with advanced SGC (including all histologic subtypes and adenoid cystic carcinoma \[ACC\]) will receive 9-ING-41 intravenously (IV) along with carboplatin IV at standard dosing together on Day 1, and 9-ING-41 alone on Day 4 of a 21-day cycle. Participants will be enrolled to two histologic cohorts: Cohort 1 will be comprised of those with ACC, and Cohort 2 will include patients with non-ACC SGC (or all other salivary gland cancer histologies). Treatment will continue until progression of disease, death, or discontinuation of therapy for any reason.

Conditions

  • Salivary Gland Carcinoma
  • Adenoid Cystic Carcinoma
  • Salivary Gland Cancer
  • Salivary Gland Neoplasms

Interventions

DRUG

9-ING-41

15 mg/kg as intravenous infusion on Days 1 and Day 4 of a 21-day cycle

DRUG

Carboplatin

Carboplatin AUC 5 intravenously on Day 1 of a 21-day cycle

Sponsors & Collaborators

  • Actuate Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Glenn J Hanna, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2030-12-18
Primary Completion
2033-06-18
Completion
2034-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04832438 on ClinicalTrials.gov