Status:
ACTIVE_NOT_RECRUITING
APG-115 in Salivary Gland Cancer Trial
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Ascentage Pharma Group Inc.
Conditions:
Malignant Salivary Gland Cancer
Salivary Gland Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase I/II trial to evaluate the efficacy of APG-115 +/- Carboplatin for the treatment p53 wild-type malignant salivary gland cancer. Part 1 consisted of 2 arms, arm A (APG-115 monotherapy)...
Detailed Description
The current single arm study design was originally part of a study with a parallel arm given combination APG-115 + Carboplatin. In the initial phase of that previous iteration, the combination arm was...
Eligibility Criteria
Inclusion
- Histologically documented malignant salivary gland cancers (including secretory glands of the aerodigestive tract) with or without metastases, not amenable to curative treatment; or there is documentation of patient refusal of curative treatment.
- Previous mutational testing with no evidence of a p53 mutation
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Presence of measurable disease by CT scan per RECIST v1.1 with ≥ 20% increase in tumor burden in the preceding 12 months
- Life expectancy of ≥12 weeks
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Patients must be able to take oral medication without breaking/opening, crushing, dissolving, or chewing capsules
- Adequate organ and marrow function obtained ≤ 2 weeks prior to enrollment
Exclusion
- Prior treatment with MDM2 inhibitors
- Patients are not eligible if they have received any systemic anti-cancer therapy (including chemotherapy and/or hormone therapy) for salivary gland cancer within 4 weeks of the start of study therapy
- Patients are not eligible if they have received any of the following within 4 weeks of the start of study therapy: live vaccines, antiretroviral drugs
- Progressive disease within 6 months of the last dose of platinum-based chemotherapy
- Patients with active brain metastases are excluded because of unknown penetration into the central nervous system (CNS). A confirmatory scan for asymptomatic patients is not required. Patients with a history of treated CNS metastases are eligible provided they meet all of the following criteria: disease outside the CNS is present, no clinical evidence of progression since completion of CNS-directed therapy, minimum 4 weeks between completion of radiotherapy and enrollment, and recovery from significant (Grade ≥ 3) acute toxicity.
- A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment
- Patients (male and female) having procreative potential who are not willing or not able to use 2 adequate methods of contraception or practicing abstinence during the study and for 90 days following their last dose of treatment
- Women who are pregnant or breast-feeding
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03781986
Start Date
October 28 2019
End Date
June 1 2026
Last Update
August 6 2025
Active Locations (3)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
University of Chicago
Chicago, Illinois, United States, 60637
3
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109