APG-115 in Salivary Gland Cancer Trial
- Conditions
- Malignant Salivary Gland CancerSalivary Gland Cancer
- Registration Number
- NCT03781986
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria:<br><br> - Histologically documented malignant salivary gland cancers (including secretory<br> glands of the aerodigestive tract) with or without metastases, not amenable to<br> curative treatment; or there is documentation of patient refusal of curative<br> treatment.<br><br> - Previous mutational testing with no evidence of a p53 mutation<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of = 1<br><br> - Presence of measurable disease by CT scan per RECIST v1.1 with = 20% increase in<br> tumor burden in the preceding 12 months<br><br> - Life expectancy of =12 weeks<br><br> - Signed and dated informed consent document indicating that the patient (or legally<br> acceptable representative) has been informed of all pertinent aspects of the trial<br> prior to enrollment<br><br> - Willingness and ability to comply with scheduled visits, treatment plans, laboratory<br> tests, and other study procedures<br><br> - Patients must be able to take oral medication without breaking/opening, crushing,<br> dissolving, or chewing capsules<br><br> - Adequate organ and marrow function obtained = 2 weeks prior to enrollment<br><br>Exclusion Criteria:<br><br> - Prior treatment with MDM2 inhibitors<br><br> - Patients are not eligible if they have received any systemic anti-cancer therapy<br> (including chemotherapy and/or hormone therapy) for salivary gland cancer within 4<br> weeks of the start of study therapy<br><br> - Patients are not eligible if they have received any of the following within 4 weeks<br> of the start of study therapy: live vaccines, antiretroviral drugs<br><br> - Progressive disease within 6 months of the last dose of platinum-based chemotherapy<br><br> - Patients with active brain metastases are excluded because of unknown penetration<br> into the central nervous system (CNS). A confirmatory scan for asymptomatic patients<br> is not required. Patients with a history of treated CNS metastases are eligible<br> provided they meet all of the following criteria: disease outside the CNS is<br> present, no clinical evidence of progression since completion of CNS-directed<br> therapy, minimum 4 weeks between completion of radiotherapy and enrollment, and<br> recovery from significant (Grade = 3) acute toxicity.<br><br> - A serious uncontrolled medical disorder or active infection that would impair their<br> ability to receive study treatment<br><br> - Patients (male and female) having procreative potential who are not willing or not<br> able to use 2 adequate methods of contraception or practicing abstinence during the<br> study and for 90 days following their last dose of treatment<br><br> - Women who are pregnant or breast-feeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Toxicity Endpoint: dose-limiting toxicity (DLT);Maximally tolerated dose (MTD);Overall response rate
- Secondary Outcome Measures
Name Time Method Overall response rate by tumor histology;Duration of response;Progression-free survival;Overall survival;Disease control rate