apg-115 in salivary gland cancer trial

Conditions: Malignant Salivary Gland Cancer; Salivary Gland Cancer

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) and arm b (apg-115 + carboplatin) and was terminated early. part 2 is a single arm study (apg-115 monotherapy).

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 closed early for issues related to tolerability of the combination therapy. this study will continue as a single arm, monotherapy alone, phase i/ii study as approved by the um institutional review board as of june 2021.

Eligibility criteria:
inclusion criteria: * 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 criteria: * 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

Keywords: p53 wild-type adenoid cystic carcinoma