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Head and Neck (HNSCC)Phase 2APACNCT07901803

Aspirin and PAClitaxel in Head & Neck Squamous Cell Carcinoma

A Phase 2 study testing Aspirin and Paclitaxel in people with Head and Neck (HNSCC) and Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), run by Washington University School of Medicine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a phase II trial of aspirin and paclitaxel in patients with recurrent/metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) who have received prior platinum and PD-1 inhibitor treatment and have an alteration in the PI3K pathway. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aspirin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
31 Dec 2026to 30 Jun 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Eligible primary tumor sub-sites include oral cavity, oropharynx, larynx, hypopharynx, nasal cavity and paranasal sinus. Also allowed:
  • P16+ (HPV-related) level 2-3 neck node and unknown primary
  • Second primary HNSCC in a previously radiated field not amenable to curative-intent surgery and/or re-radiation
  • PI3K alteration (defined in protocol) or PIK3CA amplification
  • Measurable disease per RECIST 1.1.
  • Previously treated with platinum-based chemotherapy in one of the following ways:
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  • R/M disease within 6 months of definitive cisplatin + radiation therapy (DCisRT) OR
  • R/M disease within 6 months of post-operative adjuvant cisplatin + radiation therapy (POACisRT) OR
  • Progressive disease on or after or intolerance to platinum agent given for R/M disease.
  • Previously treated with PD-1 inhibitor in one of the following ways:
  • R/M disease within 6 months of PD-1 inhibitor given as part of curative-intent therapy OR
  • Progressive disease on or after PD-1 inhibitor given for R/M disease OR
  • Intolerance to prior PD-1 inhibitor in the curative or metastatic setting OR
  • Not an appropriate candidate for PD-1 inhibitor therapy due to co-morbidity (i.e., autoimmune disease or organ/stem cell transplant)
  • At least 18 years of age.
  • ECOG performance status ≤ 2
  • Adequate bone marrow and organ function as defined below:
  • Absolute neutrophil count ≥ 1.5 K/cumm
  • Platelets ≥ 100 K/cumm
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 x IULN (≤ 3 x IULN for subjects with Gilbert's disease)
  • AST(SGOT)/ALT(SGPT)/alkaline phosphatase (ALP) ≤ 3.0 x IULN (ALP ≤ 5.0 x IULN for subjects with documented bone metastasis)
  • Creatinine clearance > 30 mL/min by Cockcroft-Gault
  • The effects of paclitaxel on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days after completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, she must inform her treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Who cannot join

  • Prior paclitaxel or docetaxel given to treat R/M HNSCC. Prior taxane in the curative-intent setting and/or for the treatment of another cancer is permitted if the last dose was administered at least 1 year prior to enrollment.
  • Palliative radiation therapy within 2 weeks of C1D1.
  • Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
  • Currently receiving any other investigational agents.
  • Recurrence, metastatic, or incurable second primary SCC of cutaneous, or nasopharynx origin.
  • Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.
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  • Concurrent oral anticoagulation for a prior history of deep venous thrombosis/pulmonary embolism or atrial fibrillation.
  • Clinically relevant major bleeding within the past 3 months (from screening).
  • Concurrent aspirin or antiplatelet therapy (e.g. clopidogrel, ticagrelor) as secondary prevention for a prior history of atherosclerotic cardiovascular disease (ASCVD) requiring intervention. ASCVD events are defined as acute coronary syndrome, myocardial infarction, stable or unstable angina, coronary or arterial revascularization, stroke, transient ischemic attack, and/or peripheral artery disease.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, aspirin, or other agents used in the study.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 14 days of study registration.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brendan Knapp, MD contact

314-747-8092

bjknapp@wustl.edu

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Brendan Knapp, MD, 314-747-8092, bjknapp@wustl.edu

    Brendan Knapp, MD

Other trials in United States

About this study

Official title: Aspirin and PAClitaxel in Recurrent/Metastatic PI3K Altered Head & Neck Squamous Cell Carcinoma (HNSCC): APAC

This is a phase II trial of aspirin and paclitaxel in patients with recurrent/metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) who have received prior platinum and PD-1 inhibitor treatment and have an alteration in the PI3K pathway.

Being tested
Aspirin, Paclitaxel
Keywords
Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma, HNSCC, aspirin, paclitaxel, PI3K altered, PIK3CA
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis, Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Aspirin is administered orally at a 162 mg dose. Aspirin will be administered each day and taken at approximately the same time every day, with or without food.

  • PaclitaxelDrug

    Also called Onxal, Abraxane

    Paclitaxel will be administered intravenously at a dose of 80 mg/m^2.

Study groups in NCT07901803
Study groupRoleWhat they receive
Paclitaxel + AspirinExperimentalPaclitaxel will be given intravenously over the course of 60 minutes on an outpatient basis on Days 1, 8, 15, and 22 of each 28-day cycle. Aspirin will be administered on an outpatient basis and taken each day of a 28-day cycle.
Receives: Drug: Aspirin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    ORR is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) as their best overall response according to RECIST v1.1.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.

    Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Start of treatment through completion of treatment or time of disease progression (total estimated time: 12 months)

Secondary outcomes (4)

  1. Incidence of protocol-specified subset of adverse events (AEs) as assessed by CTCAE v6.0

    Protocol-specified subset of AEs include AEs outside of those listed as follows: nausea, vomiting, fatigue, anemia, white blood cell decreased, neutrophil count decreased, thrombocytopenia, peripheral sensory neuropathy, peripheral motor neuropathy, infusion related reaction, bleeding/hemorrhage, weight loss, anorexia, edema, diarrhea, mucositis oral, arthralgia, and myalgia.

    For participants experiencing the same AE more than once, the maximum observed grade will be used in participant-level summaries.

    Measured: Start of treatment through 28 days after completion of treatment (total estimated time: 13 months)

  2. Duration of Response (DOR)

    DOR is defined as the time from the first documented complete response (CR) or partial response (PR) to disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Participants who are alive without documented progression will be censored at the date of their last follow-up.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.

    Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Time of CR or PR to time of disease progression or death from any cause, whichever occurs first (total estimated time: 4 years)

  3. Progression-free survival (PFS)

    PFS is defined as the time from the first dose of paclitaxel to disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Participants who are alive without documented progression will be censored at the date of their last follow-up.

    Measured: Date of first paclitaxel dose until disease progression or death from any cause (total estimated time: 4 years)

  4. Overall Survival (OS)

    OS is defined as the time from the first dose of paclitaxel to death from any cause. Participants who are alive at the time of analysis will be censored at the date of their last follow-up.

    Measured: Date of first paclitaxel dose to death from any cause (total estimated time: 4 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07901803
Sponsor's protocol ID
26-x393
Acronym
APAC
Status last verified
Oct 2026
First submitted
22 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized dataset may be available from the corresponding author on reasonable request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aspirin and Paclitaxel in people with Head and Neck (HNSCC) and Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brendan Knapp, MD (314-747-8092, bjknapp@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Start of treatment through completion of treatment or time of disease progression (total estimated time: 12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07901803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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