What side effects are associated with this type of intervention?

Common side effects of treatments for head and neck cancers, particularly those involving PI3K inhibitors like Duvelisib and chemotherapy agents like Docetaxel, include fatigue, nausea, diarrhea, and increased risk of infections due to immunosuppression. Specific to Docetaxel, patients may experience hair loss, peripheral neuropathy, and myelosuppression. Duvelisib can cause additional side effects such as elevated liver enzymes, colitis, and pneumonitis. These treatments can also lead to more severe adverse events like severe skin reactions and infusion-related reactions when combined with other agents like cetuximab.

What prior FDA approvals exist?

Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, has received FDA approval for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This approval provides a treatment option that leverages the immune system to combat cancer, similar to the investigational use of Duvelisib, which targets the PI3K pathway. Additionally, Docetaxel, a chemotherapy agent, is commonly used in various regimens for HNSCC, often in combination with other drugs to enhance efficacy.

What other types of research exist?

Promising novel alternatives for head and neck cancer treatment include: 1) Afatinib, an irreversible ERBB family blocker, which has shown efficacy in phase 2 and 3 trials. 2) Bevacizumab, an anti-angiogenic agent, which has demonstrated increased response rates and longer progression-free survival, though with increased toxicity. 3) Pembrolizumab, an immunotherapy checkpoint inhibitor, particularly for tumors with high tumor mutational burden (TMB). 4) Foretinib, a multikinase inhibitor targeting MET and VEGFR2, which has shown activity in phase 2 trials.

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Chemotherapy

Duvelisib + Docetaxel for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Glenn J. Hanna, MD

Research Sponsored by Glenn J. Hanna

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be ≥18 years of age on the day of signing informed consent

Participants must have adequate organ and marrow function as defined below (within 14 days prior to study registration): absolute neutrophil count ≥ 1,000/mcL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/mcL, total bilirubin ≤ upper limit of normal (ULN), AST(SGOT)/ALT(SGPT) ≤ 2.5x institutional ULN (or ≤ 1.5x institutional ULN if concomitant with alkaline phosphatase >2.5x institutional ULN) or ≤ 5x ULN for those with liver metastases, serum creatinine ≤ 1.5x ULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above 1.5x ULN, coagulation profile INR ≤ 1.5x ULN unless the participant is receiving an anticoagulant

Must not have

Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Concurrent administration of other cancer specific therapy or investigational agents during the course of this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of a pill (Duvelisib) and an IV drug (Docetaxel) for patients with head and neck cancer that has come back or spread. These patients did not respond to initial treatments. Duvelisib stops cancer cells from growing, and Docetaxel kills them by preventing cell division.

Who is the study for?

Adults with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), who have had no more than two prior systemic therapies, one including PD-1/L1 blockade. They must not have used PI3K inhibitors before, be in good health otherwise, and agree to use contraception.

What is being tested?

The trial is testing duvelisib combined with docetaxel chemotherapy in patients with SCCHN that has returned or spread. Duvelisib is a PI3K inhibitor which may help stop cancer growth by targeting specific cells.

What are the potential side effects?

Duvelisib can cause diarrhea, fever, fatigue, rash, coughing; while docetaxel may lead to hair loss, nail changes, numbness in fingers/toes. Both drugs might lower blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My blood, liver, and kidney functions meet the study's health requirements.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have a tumor that can be measured by scans.

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My cancer is a type of throat or mouth cancer that has come back or spread and cannot be cured.

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I agree to use birth control or abstain from sex during and for 4 months after the study.

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It's been over 2 weeks since my last cancer treatment, and I've mostly recovered.

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I've had 1-2 treatments for my cancer, including one targeting PD-1/L1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer that has spread to my brain or spinal cord.

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I am not taking any other cancer treatments or experimental drugs during this study.

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I have been treated with a PI3K pathway inhibitor before.

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I have had 3 or more treatments for my recurring or metastatic head and neck cancer.

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I received radiation therapy within the last 14 days before starting duvelisib.

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I do not have any severe illnesses like heart failure or recent strokes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best overall response rate

Secondary study objectives

Duration of therapeutic response

Number of Participants with treatment related Adverse Events per CTCAE 5.0

Overall Survival

+1 more

Side effects data

From 2021 Phase 3 trial • 319 Patients • NCT02004522

50%

Diarrhoea

34%

Neutropenia

29%

Pyrexia

25%

Anaemia

24%

Nausea

23%

Cough

17%

Thrombocytopenia

17%

Constipation

16%

Fatigue

16%

Pneumonia

15%

Vomiting

15%

Decreased appetite

14%

Upper respiratory tract infection

13%

Asthenia

13%

Colitis

13%

Weight decreased

13%

Bronchitis

11%

Abdominal pain

11%

Rash

10%

Hypokalaemia

10%

Oedema peripheral

Aspartate aminotransferase increased

Dyspnoea

Alanine aminotransferase increased

Back pain

Dizziness

Headache

Hypertension

Nasopharyngitis

Arthralgia

Pruritus

Hyperkalaemia

Respiratory tract infection

Rash maculo-papular

Febrile neutropenia

Rhinorrhoea

Dyspepsia

Pain in extremity

Abdominal pain upper

Dehydration

Insomnia

Productive cough

Dry mouth

Muscle spasms

Paraesthesia

Pneumonitis

Toxic skin eruption

Renal failure acute

Hypotension

General physical health deterioration

Gastroenteritis

Gastritis

Pneumonia pseudomonas aeruginosa

Pancytopenia

Cardiac failure

Sepsis

Pneumocystis jirovecii pneumonia

Pneumonia pneumococcal

Pulmonary embolism

Urinary tract infection

Pneumonia klebsiella

Respiratory failure

Streptococcal sepsis

Interstitial lung disease

Skin infection

Accidental overdose

Pneumonia staphylococcal

Rash erythematous

Pneumonia aspiration

Fungal oesophagitis

Pleural haemorrhage

Upper gastrointestinal haemorrhage

Proctitis

Enterocolitis

Mental impairment

Intestinal adenocarcinoma

Deep vein thrombosis

Haemolytic anaemia

Atrial fibrillation

Cardiac failure congestive

Myocardial infarction

Pericarditis

Death

Mucosal inflammation

Multi-organ failure

Sudden death

Transitional cell carcinoma

Bronchiolitis

Bronchitis viral

Bronchopneumonia

Cytomegalovirus colitis

Pneumonia escherichia

Pneumonia mycoplasmal

Septic shock

Streptococcal bacteraemia

Subdural haematoma

Lipase increased

Nephrolithiasis

Renal colic

Renal failure

Renal failure chronic

Lung disorder

Ventricular tachycardia

Colitis ischaemic

Enteritis

Pancreatitis acute

Ileal ulcer

Aspergillus infection

Bronchopulmonary aspergillosis

Campylobacter gastroenteritis

Clostridium difficile colitis

Fungal infection

Influenza

Pseudomonal sepsis

Lower respiratory tract infection

Pneumonia bacterial

Enterococcal infection

Enterococcal sepsis

Escherichia sepsis

Escherichia urinary tract infection

Gastroenteritis viral

Haemophilus infection

Infection

Infusion site cellulitis

Lobar pneumonia

Lower respiratory tract infection viral

Lung infection

Pneumonia respiratory syncytial viral

Pneumonia streptococcal

Pseudomonas bronchitis

Wound infection staphylococcal

Cervical vertebral fracture

Femur fracture

Traumatic haematoma

Malnutrition

Hyponatraemia

Tumour lysis syndrome

Arthritis

Bone pain

Malignant melanoma

Brain stem haemorrhage

Dementia

Acute respiratory distress syndrome

Acute respiratory failure

Chronic obstructive pulmonary disease

Dermatitis exfoliative

Thrombosis

Infusion related reaction

Neuroendocrine tumour

Pleural effusion

Mallory-Weiss syndrome

Diverticulitis

Pyelonephritis

Haemorrhagic stroke

Dermatitis allergic

Respiratory tract infection bacterial

Splenic rupture

Neuroendocrine carcinoma of the skin

100%

80%

60%

40%

20%

Study treatment Arm

Duvelisib

Ofatumumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Duvelisib plus Docetaxel chemotherapyExperimental Treatment2 Interventions

Participants will receive duvelisib by mouth twice daily,dosage per protocol continuously (days 1-21 of a 21-day cycle) with a 7-day lead-in planned prior to the start of taxane therapy. Docetaxel at via IV will be delivered on day 1 of each 21-day cycle. Treatment will continue for 24-months or until unacceptable toxicity, progression, or death.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Duvelisib

2016

Completed Phase 3

~760

Docetaxel

1995

Completed Phase 4

~6550

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The treatment of Head and Neck Cancers often involves targeted therapies and chemotherapy. Duvelisib, a PI3K inhibitor, works by blocking the PI3K pathway, which is crucial for cancer cell growth and survival. By inhibiting this pathway, Duvelisib can reduce tumor growth and potentially enhance the effectiveness of other treatments. Docetaxel, a chemotherapy agent, disrupts cell division by stabilizing microtubules, leading to cell death. This is particularly important for rapidly dividing cancer cells. These mechanisms are significant for patients as they target specific pathways involved in cancer progression, potentially improving treatment outcomes and offering new hope for those with recurrent or metastatic disease.