Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Phase I/II Trial of Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 120 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 years
- Procedures mentioned: Blood draws, Biopsies, Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "They will have blood tests, imaging scans, and a test of their heart function."
- "A tissue sample (biopsy) of the tumor may be taken."
- "SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle."
- "Follow-ups will continue every 3 months for 2 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a new drug, SX-682, with an approved cancer drug, docetaxel. It is for adults with certain head and neck cancers that have returned, spread, or cannot be cured, or prostate cancer that has spread and is growing despite low testosterone.
Background: Head and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed. Objective: To test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer. Eligibility People aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread. Design: Participants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken. Participants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles. Participants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, able to care for yourself, and out of bed or a chair for at least half of your waking hours.
- Have blood tests showing that your blood cell levels, kidneys, liver, and blood clotting meet study limits.
- Be able to swallow pills, understand the study, and sign a consent form.
- For head and neck cancer: have a confirmed eligible cancer and at least one tumor that can be measured. Some types require past chemotherapy or immune treatment; salivary gland cancer does not require past treatment.
- For prostate cancer: have cancer that has spread and is getting worse despite very low testosterone. You must have had certain hormone-blocking drugs and need ongoing testosterone-lowering treatment unless your testicles were removed.
- Past treatment side effects must meet recovery limits. If you had docetaxel for prostate cancer resistant to hormone treatment, the cancer must not have worsened during treatment or within 3 months after it ended.
- If you or your partner could become pregnant, agree to birth control during treatment and afterward: 2 months for women and 4 months for men. Men must not freeze or donate sperm during that time. Stop breastfeeding during treatment and for 1 week afterward.
- If you have HIV or long-term hepatitis B or C, virus levels must be too low to detect. People with HIV must also meet treatment and past-infection rules.
Who can't join
- Allergies to drugs or ingredients like those used in this study.
- Active cancer in the brain. Previously treated brain cancer may be allowed if it is stable and meets other study rules.
- Other study drugs within 3 weeks, major surgery within 14 days, or poor recovery from surgery.
- Medicines that strongly or moderately change how the body breaks down the study drugs, taken too close to treatment.
- Another cancer or a serious, uncontrolled illness that could make treatment unsafe or affect study results.
- For head and neck cancer: cancer medicines within 3 weeks, radiation to a large area within 2 weeks, or side effects that have not recovered enough. Some ongoing medicines are allowed.
- For head and neck cancer: a positive pregnancy test.
- For prostate cancer: certain urinary medicines or supplements that change PSA blood test results within 1 week; cancer-related nerve damage; or a heart rhythm test result called QTcF of 470 milliseconds or higher.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* INCLUSION CRITERIA: All Participants * Age \>= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2 * Participants must have adequate organ and marrow function as defined below: * ANC \>= 1,500/mcL * Hemoglobin (Hgb) \>= 9 g/dL * Platelets (PLTs) \>= 100,000/mcL * Creatinine clearance \>= 50 mL/min (by Cockroft-Gault formula) * Total bilirubin \<= 1.5 x iULN (\<= 3 x ULN in participants with known/suspected Gilbert s disease) * ALT/AST \<= 2.5 x iULN * Activated partial thromboplastin time (aPTT) \<= 1.5 x iULN * Contraception as follows: * Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \[IUD\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement. * Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period. * Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs. * Participants must be able to swallow oral medications. * Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation. * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL. * Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL. * Participants must be able to understand and willing to sign a written informed consent document. Participants with HNC * Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent/metastatic (R/M) or advanced incurable disease. * Prior treatment as follows: * Participants with R/M HNSCC must have prior systemic treatment (platinum-based chemotherapy and/or anti-PD(L)1 treatment). * Participants with R/M SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation. * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \<2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment. * Presence of \>= 1 measurable lesion by RECIST v 1.1 criteria. Participants with mCRPC * Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease. * Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1. * Participants must need ADT as part of their cancer therapy (unless previous orchiectomy) * Castrate testosterone level (\<50 ng/dl or 1.7 nmol/L) * Prior treatment as follows: * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide. * Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan. * Toxicities related to prior therapy, including surgery and/or radiation, must have resolved to \< Grade 1 per CTCAE v.6.0. EXCLUSION CRITERIA: All participants * History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80). * Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment * Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s). * Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and/or complications from the intervention prior to starting study treatment. * Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment. * Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment. * Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements. Participants with HNC * Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \<2 (except for radiation-induced xerostomia/dysgeusia) or be minimal and not constitute a safety risk. * Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test Participants with mCRPC * Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation. * Cancer related neuropathy at screening * Baseline QTcF \>= 470 ms
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892National Cancer Institute Referral Office · Study contact · 888-624-1937 · ncimo_referrals@mail.nih.govMore trials in Bethesda