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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
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 moreSide effects data
From 2021 Phase 3 trial • 319 Patients • NCT0200452250%
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%
Dyspnoea
9%
Aspartate aminotransferase increased
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Arthralgia
7%
Pruritus
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%
Toxic skin eruption
3%
Renal failure acute
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%
Enterocolitis
1%
Urinary tract infection
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Pneumonia aspiration
1%
Interstitial lung disease
1%
Respiratory failure
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia klebsiella
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Proctitis
1%
Pneumonia staphylococcal
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
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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited for this research project?
"Affirmative. According to information found on clinicaltrials.gov, this medical experiment is undergoing recruitment as of now. The trial was initially posted on October 14th 2021 and has since been amended on September 19th 2022. 26 participants are required from one single location for the study to be successful."
Answered by AI
Are there any remaining openings for enrolment in this clinical trial?
"Affirmative. On clinicaltrials.gov, this research project is listed as actively recruiting participants - it was initially posted on October 14th 2021 and last modified on September 19th 2022. 26 subjects are needed from 1 medical site."
Answered by AI
What medical condition does Duvelisib typically help alleviate?
"Duvelisib can be used to address various conditions such as esophageal neoplasms malignant, non-small cell lung carcinoma, and refractory anemias."
Answered by AI
What past experiments have included Duvelisib in their research?
"Currently, 335 clinical studies are investigating Duvelisib with 126 of them in the third phase. Most trials for this drug are taking place around Saint Louis, Missouri but there is also a sizable presence at over 22535 other sites throughout the world."
Answered by AI
Has Duvelisib been granted authorization by the Federal Drug Administration?
"Based on the available data, duvelisib was given a score of 2 for safety as this is only in Phase 2 clinical trials. Although there are indications that it might be safe, no evidence has been provided to suggest its efficacy yet."
Answered by AI
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