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Anti-androgen

Enzalutamide for Salivary Gland Cancer

Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any number of prior lines of therapy
No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 32 months post study enrollment
Awards & highlights

Study Summary

This study is evaluating whether a drug called enzalutamide can shrink the cancer in people with salivary gland cancer.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 32 months post study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 months post study enrollment 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
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
Progression-free Survival

Side effects data

From 2021 Phase 4 trial • 255 Patients • NCT02485691
40%
Diarrhoea
30%
Anaemia
29%
Fatigue
26%
Asthenia
23%
Nausea
22%
Neutropenia
16%
Back Pain
15%
Constipation
14%
Haematuria
13%
Vomiting
13%
Decreased Appetite
12%
Dysgeusia
8%
Abdominal Pain
8%
Urinary Tract Infection
8%
Arthralgia
8%
Stomatitis
8%
Oedema Peripheral
7%
Cancer Pain
6%
Polyneuropathy
6%
Alopecia
6%
Leukopenia
6%
Dyspnoea
6%
Pyrexia
6%
Pain
6%
Neuropathy Peripheral
5%
Pain In Extremity
4%
Weight Decreased
4%
Hypokalaemia
4%
Hypertension
3%
Disease Progression
3%
Bone Pain
3%
Febrile Neutropenia
3%
Spinal Cord Compression
3%
Pneumonia
2%
Acute Kidney Injury
2%
Atrial Fibrillation
2%
Sepsis
1%
Rectal Haemorrhage
1%
Malaise
1%
Gamma-Glutamyltransferase Increased
1%
Diarrhoea Haemorrhagic
1%
Gastroenteritis
1%
Neutropenic Infection
1%
Hydronephrosis
1%
Inflammation
1%
Oncologic Complication
1%
Flank Pain
1%
Spinal Pain
1%
Platelet Count Decreased
1%
Urinary Retention
1%
Femoral Neck Fracture
1%
Loss Of Consciousness
1%
Pathological Fracture
1%
Tumour Pain
1%
Aspiration
1%
Atrial Flutter
1%
Vertigo
1%
General Physical Health Deterioration
1%
Transient Ischaemic Attack
1%
Hepatitis
1%
Toxicity To Various Agents
1%
Alanine Aminotransferase Increased
1%
Pancytopenia
1%
Neuroendocrine Carcinoma Of The Skin
1%
Carotid Artery Stenosis
1%
Syncope
1%
Haemoptysis
1%
Septic Shock
1%
Device Related Sepsis
1%
Laryngeal Inflammation
1%
Perineal Cellulitis
1%
Urosepsis
1%
Head Injury
1%
Cognitive Disorder
1%
Aspartate Aminotransferase Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabazitaxel
Enzalutamide or Abiraterone

Trial Design

1Treatment groups
Experimental Treatment
Group I: EnzalutamideExperimental Treatment1 Intervention
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,588 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,600 Total Patients Enrolled
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,787 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025