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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

Study Summary

This trial is testing a new combination drug therapy for men with prostate cancer that has spread and is no longer responding to hormone therapy.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion at up to approximately 63 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6-month radiographic progression-free survival

Secondary outcome measures

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

Urinary tract infection

Alanine aminotransferase increased

Pneumothorax

Hypokalaemia

Respiratory failure

Pneumonia bacterial

Hypotension

Sepsis

Constipation

Hyponatraemia

Anaemia

Brain death

Haematuria

Ischaemic hepatitis

Candida infection

Septic shock

Pneumonia

Atrial fibrillation

Multiple organ dysfunction syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Abivertinib With Standard of Care

Placebo With Standard of Care

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

Do I qualify?Apply below to find out

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Abivertinib met the standards of a regulatory body?

"Abivertinib has only been tested in Phase 2 trials, so its safety rating is a two. This reflects the available evidence indicating safety but not efficacy."

Answered by AI

Are there any remaining slots available for participants in this research study?

"As per clinicaltrials.gov, this trial is no longer enrolling participants as of May 2nd 2022. Though the study has reached its recruitment quota, there are an additional 1,321 trials actively recruiting patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer

2025. "Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05361915.