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

NCT04832438 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

advanced; metastatic; 9-ING-41; carboplatin; refractory

Outcome Measures

Primary Outcomes (1)

• Number of evaluable patients with objective response as measured by RECIST version 1.1

  Response and progression will be evaluated in this study using the international Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.

  3-24 months

Study Arms (1)

9-ING-41 plus carboplatin

EXPERIMENTAL

Patients will receive 9-ING-41 (15 mg/kg IV on Day 1 and Day 4) in addition to carboplatin (AUC 5 IV on Day 1) each of a 21-day cycle

Drug: 9-ING-41; Drug: Carboplatin

Interventions

9-ING-41 DRUG

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

9-ING-41 plus carboplatin

Carboplatin DRUG

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

9-ING-41 plus carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants must have at least one RECIST v1.1 measurable non-CNS based lesion.

You may not qualify if:

• Metastatic disease impinging on the spinal cord or threatening spinal cord compression. Patients that have had previous treatment of disease with impinging on the cord with either surgery or radiotherapy with clinical or radiographic evidence of response or stability are eligible.
• Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment), and have no evidence of new or enlarging brain metastases.
• Concurrent administration of other cancer specific therapy or investigational agents during the course of this study is not allowed.
• Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Pregnant or lactating women.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.

Sponsors & Collaborators

• Actuate Therapeutics Inc.: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Carcinoma, Adenoid Cystic; Neoplasm Metastasis

Interventions

3-(5-fluorobenzofuran-3-yl)-4-(5-methyl-5H-(1,3)dioxolo(4,5-f)indol-7-yl)-pyrrole-2,5-dione; Carboplatin

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Glenn J Hanna, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start (Estimated): December 18, 2030
• Primary Completion (Estimated): June 18, 2033
• Study Completion (Estimated): June 18, 2034
• Last Updated: February 22, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)