Health Trials

Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer

ConditionsHead and Neck CancerHead and Neck Squamous Cell CarcinomaParanasal Sinus NeoplasmsNasopharyngeal CarcinomaOropharyngeal Squamous Cell CarcinomaHypopharyngeal CancerCarcinoma of LarynxOral Squamous Cell CarcinomaSalivary Gland CancerAdenoid Cystic CarcinomaProstate CancerMetastatic Castration Resistant Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2

ANC >= 1,500/mcL

Hemoglobin (Hgb) >= 9 g/dL

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SX-682

    Drug

    SX-682 will be given orally (PO) twice a day at the dose of the corresponding dose level group (for Phase I) or at RP2D (for Phase II).

  • DTX

    Drug

    DTX will be administered IV at 75 mg/m\^2 over about 60 minutes

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 2 interventions
Group B: Arm 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase I: To determine the RP2D of SX-682 in combination with DTX in participants with HNSCC, SGC, or mCRPC

Toxicities will be tabulated and reported according to grade and type of toxicity experienced. Responses will be reported as the proportion of evaluable participants along with a confidence interval.

Time frame
28 days
2

Phase II: To determine the efficacy of the combination of SX-682 and DTX in participants with HNSCC or SGC using ORR per RECIST v 1.1 or with mCRPC using RECIST v1.1 and Prostate Cancer Working Group 3

Overall response rate (ORR) as defined by the proportion of participants who achieve a response (CR+PR) will be reported separately for each, along with 95% and 80% confidence intervals (Clopper-Pearson).

Time frame
Assessment at baseline, C4D8, 7 days after C6, and then every 3 months until PD or until 2 years after study treatment initiation

Secondary outcomes

1

To assess safety of SX-682 in combination with DTX

Toxicity will be reported descriptively for each cohort separately.

Time frame
Assessed from the first study treatment, C1D1, through safety visit (28 days post-treatment) or start of new anticancer treatment, whichever comes first.
2

To assess progression free survival (PFS)

PFS will be determined separately by cohort using Kaplan-Meier plots. Medians and 95% confidence intervals will be provided for each of these secondary objectives. PFS will be determined separately for 6, 12 and 24 months.

Time frame
Assessed at C1D1, C4D8, 7 days after C6, and then every 3 months until PD or until 2 years after study treatment initiation.
3

To assess overall survival (OS)

OS will be determined separately by cohort using Kaplan-Meier plots. Medians and 95% confidence intervals will be provided for each of these secondary objectives. OS will be determined separately for 2 and 5 years.

Time frame
Assessed at C1-6D1, at the 28-day Safety visit; every 3 months until disease progression or 2 years after start of study treatment; every 6 months after disease progression until 5 years after start of study treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: