Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head an… (NCT05245682) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer
United States10 participantsStarted 2022-02-17
Plain-language summary
This early-phase trial tests the safety and side effects of a tolinapant given together with radiation therapy in treating patients with head and neck cancer for which the patient has not received treatment in the past (previously untreated), has spread to nearby tissue or lymph nodes (locally advanced) and cannot receive cisplatin (cisplatin-ineligible). Tolinapant may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tolinapant and radiation therapy may kill more tumor cells.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or Female.
✓. Age ≥18 years.
✓. ECOG performance status ≤1 (see Appendix A).
✓. Patients with histologically or cytologically confirmed diagnosis of HNSCC, previously untreated and locally advanced, for whom definitive or adjuvant radiation is planned but cisplatin chemotherapy is contraindicated.
✓. Acceptable organ function, as evidenced by the following laboratory data:
✓. The effects of tolinapant on the developing human fetus are unknown. For this reason and because tolinapant as well as other therapeutic agents used in this trial are known to be teratogenic, females of child-bearing potential (FCBP) must have a negative serum pregnancy test prior to starting therapy.
✓. Female patients of childbearing potential and men must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study participation and for at least 6 months following study drug discontinuation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (if age \> 55 years); if the female subject is \< 55 years and she has been naturally postmenopausal for \> 1 year her reproductive status has to be verified by additional lab tests (\< 20 estradiol OR estradiol \< 40 with FSH \> 40 in women not on estrogen replacement therapy).
What they're measuring
1
Safety of Tolinapant + Radiation (Number of Patients With Adverse Events Per CTCAE v5.0)
Timeframe: Up to 60 days post-treatment
2
Feasibility of Tolinapant + Radiation (Number of Patients Able to Complete Treatment)
✓. Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol specified laboratory tests, other study procedures, and study restrictions.
Exclusion criteria
✕. Patients who have had prior radiotherapy to the head and neck region
✕. Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tolinapant.
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
✕. Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure (or ejection fraction \<50%); or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy.
✕. Contraindications to radiotherapy (e.g. uncontrolled connective tissue disorder).
✕. Women who are pregnant or breast feeding.
✕. Vulnerable populations including prisoners and adults who are unable to consent.