APG-115 in Salivary Gland Cancer Trial

  • STATUS
    Recruiting
  • End date
    Jan 21, 2025
  • participants needed
    34
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 21 March 2022

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).

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 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.

Details
Condition Malignant Salivary Gland Cancer, Salivary Gland Cancer
Treatment carboplatin, APG-115, Part 2, APG115 mono-therapy, APG115 + Carboplatin
Clinical Study IdentifierNCT03781986
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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