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Safety and Efficacy of APG-157 in Head and Neck Cancer
Study Purpose
The purpose of this clinical research study is to study safety and efficacy of orally administered APG-157 as the neoadjuvant/induction therapy in newly diagnosed, locally advanced patients with Head & Neck Cancer of oral cavity and/or oropharynx. The study hypothesis is that neoadjuvant use of APG-157 will reduce the tumor burden prior to any definitive therapy to improve the outcomes over current standard of care.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
A. Biopsy proven oral cavity or oropharyngeal Squamous Cell Carcinoma. B. Newly diagnosed, treatment naive Stage I, Stage II, Stage III or Stage IV HNSCC patients. Staging is done according to the International Union Against Cancer's (UICC) classification system for oral cancer. Acceptable TNM staging is T1-4, N0-2, M0. C. Patients who are scheduled to receive the following therapy after APG-157 treatment. 1. Local Therapy with Curative Intent Surgery alone or surgery followed by radiation. 2. Therapy with Palliative Intent Radiation alone. Radiation with concurrent radiosensitizing chemotherapeutic agents only using QUAD-shot protocol. Radiosensitizing chemotherapeutic agents are limited to carboplatin or cetuximab. 3. Patients who refuse surgery or are unfit for any local therapy.Exclusion Criteria:
A. Patients whose definitive, local treatment is available in less than four weeks from initial diagnosis. For example, some patients who are scheduled to receive chemo-radiation therapy as the local therapy with curative intent. B. Pregnant women. C. Prior Chemotherapy or radiation therapy within the last 8 weeks. D. Patients with recurrent or metastatic cancer. E. Tooth abscesses. F. Bleeding gums or cracked teeth. G. Patients who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks. H. Patients who have had a fracture of the mandible or maxilla within the previous 8 weeks.- I. Inability to complete enrollment forms due to any mental status or language problems
(e.g. dementia, head injury, overall illness).
J. Patients with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
The patient will receive neoadjuvant therapy (APG-157) during the period between initial diagnosis and time of definitive treatment. APG-157 is an orally administered drug in a form of pastille (soft lozenge) taken three times a day. It dissolves in the mouth. After the neoadjuvant treatment, the patient undergoes surgery or any other definitive therapy and/or postoperative radiotherapy as determined by the patient's doctor. Duration of treatment is four weeks that may be extended up to six weeks by mutual consent of the patients and the investigators. Objectives: 1. To conduct Phase 2A to determine how tumor size, tumor tissue biomarkers, and the cancer stem cell markers, in head and neck squamous cell cancer patients are affected by the administration APG-157 pastilles using imaging and other clinical measurements. 2. To determine the degrees of response of each patient to APG-157 (considering patient's diagnosis/staging and local treatment) using proposed primary, secondary and exploratory endpoints. 3. The results from this study will be used to finalize the design of subsequent Phase 2B study (single arm for specific patient population and local treatment) to demonstrate statistically significant efficacy outcomes.
Arms
Experimental: APG-157
Two pastilles (100 mg) taken three times a day (i.e. before meal time).
Interventions
Drug: - APG-157
Treatment
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
VAGLAHS, West Los Angeles
Los Angeles, California, 90073
Site Contact
Marilene B Wang, MD
[email protected]
310-268-3748
Status
Recruiting
Address
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Site Contact
Elizabeth Franzmann, MD
[email protected]
305-243-5955
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