← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is investigating whether adding duvelisib to docetaxel chemotherapy can help to treat squamous cell carcinoma of the head and neck (SCCHN) that has returned or spread to other parts of the body.

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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
My blood, liver, and kidney functions meet the study's health requirements.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have a tumor that can be measured by scans.
Select...
My cancer is a type of throat or mouth cancer that has come back or spread and cannot be cured.
Select...
I agree to use birth control or abstain from sex during and for 4 months after the study.
Select...
It's been over 2 weeks since my last cancer treatment, and I've mostly recovered.
Select...
I've had 1-2 treatments for my cancer, including one targeting PD-1/L1.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best overall response rate
Secondary outcome measures
Duration of therapeutic response
Number of Participants with treatment related Adverse Events per CTCAE 5.0
Overall Survival
+3 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%
Colitis
13%
Asthenia
13%
Weight decreased
13%
Bronchitis
11%
Abdominal pain
11%
Rash
10%
Hypokalaemia
10%
Oedema peripheral
9%
Aspartate aminotransferase increased
9%
Dyspnoea
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Pruritus
7%
Arthralgia
7%
Hyperkalaemia
7%
Respiratory tract infection
6%
Rash maculo-papular
6%
Febrile neutropenia
6%
Rhinorrhoea
6%
Dyspepsia
6%
Pain in extremity
6%
Abdominal pain upper
5%
Dehydration
5%
Insomnia
5%
Productive cough
5%
Dry mouth
4%
Muscle spasms
4%
Paraesthesia
4%
Pneumonitis
3%
Renal failure acute
3%
Toxic skin eruption
3%
Hypotension
3%
General physical health deterioration
3%
Gastroenteritis
2%
Gastritis
2%
Pneumonia pseudomonas aeruginosa
2%
Pancytopenia
2%
Cardiac failure
2%
Sepsis
2%
Pneumocystis jirovecii pneumonia
2%
Pneumonia pneumococcal
2%
Pulmonary embolism
1%
Urinary tract infection
1%
Pneumonia klebsiella
1%
Pneumonia staphylococcal
1%
Interstitial lung disease
1%
Enterocolitis
1%
Skin infection
1%
Mental impairment
1%
Upper gastrointestinal haemorrhage
1%
Streptococcal sepsis
1%
Respiratory failure
1%
Rash erythematous
1%
Proctitis
1%
Pneumonia aspiration
1%
Pleural haemorrhage
1%
Fungal oesophagitis
1%
Accidental overdose
1%
Intestinal adenocarcinoma
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Pericarditis
1%
Death
1%
Mucosal inflammation
1%
Multi-organ failure
1%
Sudden death
1%
Transitional cell carcinoma
1%
Bronchiolitis
1%
Bronchitis viral
1%
Bronchopneumonia
1%
Cytomegalovirus colitis
1%
Pneumonia escherichia
1%
Pneumonia mycoplasmal
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Subdural haematoma
1%
Lipase increased
1%
Nephrolithiasis
1%
Renal colic
1%
Renal failure
1%
Renal failure chronic
1%
Lung disorder
1%
Ventricular tachycardia
1%
Colitis ischaemic
1%
Enteritis
1%
Pancreatitis acute
1%
Ileal ulcer
1%
Aspergillus infection
1%
Bronchopulmonary aspergillosis
1%
Campylobacter gastroenteritis
1%
Clostridium difficile colitis
1%
Fungal infection
1%
Influenza
1%
Pseudomonal sepsis
1%
Lower respiratory tract infection
1%
Pneumonia bacterial
1%
Enterococcal infection
1%
Enterococcal sepsis
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Gastroenteritis viral
1%
Haemophilus infection
1%
Infection
1%
Infusion site cellulitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection viral
1%
Lung infection
1%
Pneumonia respiratory syncytial viral
1%
Pneumonia streptococcal
1%
Pseudomonas bronchitis
1%
Wound infection staphylococcal
1%
Cervical vertebral fracture
1%
Femur fracture
1%
Traumatic haematoma
1%
Malnutrition
1%
Hyponatraemia
1%
Tumour lysis syndrome
1%
Arthritis
1%
Bone pain
1%
Malignant melanoma
1%
Brain stem haemorrhage
1%
Dementia
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Dermatitis exfoliative
1%
Thrombosis
1%
Infusion related reaction
1%
Neuroendocrine tumour
1%
Pleural effusion
1%
Mallory-Weiss syndrome
1%
Diverticulitis
1%
Pyelonephritis
1%
Haemorrhagic stroke
1%
Dermatitis allergic
1%
Respiratory tract infection bacterial
1%
Splenic rupture
1%
Neuroendocrine carcinoma of the skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duvelisib
Ofatumumab

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
~5620

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.

Find a Location

Who is running the clinical trial?

Glenn J. HannaLead Sponsor
3 Previous Clinical Trials
94 Total Patients Enrolled
Secura Bio, Inc.Industry Sponsor
8 Previous Clinical Trials
222 Total Patients Enrolled
Glenn J. Hanna, MDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Head and Neck Cancers Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT05057247 — Phase 2
~7 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top