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Hormone Therapy

Abivertinib for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by Sorrento Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion at up to approximately 63 months
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, abivertinib and abiraterone, to treat prostate cancer that has spread and does not respond to typical treatments. The goal is to see if this combination can stop the cancer from growing by cutting off its fuel supply and blocking its survival routes. The study includes patients who have never taken abiraterone and those whose cancer has progressed despite taking it. Abiraterone has been used to improve overall survival in men with metastatic castration-resistant prostate cancer, but resistance to it can limit its effectiveness.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion at up to approximately 63 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion at up to approximately 63 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6-month radiographic progression-free survival
Secondary study objectives
6-month radiographic progression-free survival (rPFS)
Duration of response
Overall Response Rate
+5 more

Side effects data

From 2021 Phase 2 trial • 96 Patients • NCT04440007
19%
Hyperglycaemia
13%
Leukocytosis
13%
Acute kidney injury
13%
Acute respiratory failure
10%
Thrombocytopenia
10%
Hepatic enzyme increased
8%
Alanine aminotransferase increased
8%
Urinary tract infection
8%
Pneumothorax
6%
Respiratory failure
6%
Hypokalaemia
6%
Pneumonia bacterial
6%
Hypotension
6%
Sepsis
6%
Constipation
4%
Hyponatraemia
4%
Anaemia
2%
Brain death
2%
Haematuria
2%
Ischaemic hepatitis
2%
Candida infection
2%
Septic shock
2%
Pneumonia
2%
Atrial fibrillation
2%
Multiple organ dysfunction syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abivertinib With Standard of Care
Placebo With Standard of Care

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Abivertinib - Abiraterone-progressingExperimental Treatment2 Interventions
Abiraterone-progressing: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
Group II: Abivertinib - Abiraterone-naiveExperimental Treatment2 Interventions
Abiraterone-naive: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abivertinib
Not yet FDA approved
Abiraterone
FDA approved

Find a Location

Who is running the clinical trial?

Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
1,864 Total Patients Enrolled
Mike Royal, MDStudy DirectorSorrento Therapeutics, Inc.
27 Previous Clinical Trials
1,395 Total Patients Enrolled
~67 spots leftby Jan 2028
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