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PI3K inhibitor

Copanlisib + Rucaparib for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Benedito Carneiro, MD, MS
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Progressive disease during/within 4 weeks of completion with abiraterone, enzalutamide, and/or apalutamide (measurable disease by RECIST 1.1 criteria, PSA evidence, or radionuclide bone scan)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 (each cycle is 28 days) through pre-dosing cycle 2, approximately 1 month.
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining copanlisib and rucaparib. The treatment will be given until it is no longer working or the patient experiences side effects.

Who is the study for?
Adults with metastatic castration-resistant prostate cancer who've progressed after certain treatments can join. They need a life expectancy of at least 3 months, acceptable organ function, and no recent serious cardiovascular events or other cancers in the last 5 years. Men must use contraception during and post-treatment for 6 months.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Copanlisib and Rucaparib. It's an open-label study where all participants receive the same treatment to assess safety, how the body processes the drugs, and their effectiveness against prostate cancer.See study design
What are the potential side effects?
Possible side effects include blood pressure changes, immune system reactions, liver enzyme alterations, fatigue, nausea, risk of infections due to low blood cell counts, heart issues like irregular heartbeat or reduced heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer has worsened despite treatment with abiraterone, enzalutamide, or apalutamide.
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My prostate cancer is worsening even though my testosterone is very low.
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I agree to provide a sample of my tumor for testing.
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I have confirmed prostate cancer, including if it has changed to a neuroendocrine type but not if it started as small cell cancer.
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My testosterone level is below 50 ng/dL, and I am on hormone therapy unless I've had both testicles removed.
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I haven't had any prostate cancer treatments in the last 21 days or 5 half-lives.
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My cancer has specific DNA repair gene mutations.
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I am 18 years old or older.
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My prostate cancer is spreading and my testosterone is very low.
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My prostate cancer diagnosis was confirmed through tissue examination.
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My PSA levels have been rising, showing my prostate cancer is progressing.
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I am 18 years old or older.
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My cancer can be either visible on scans or not.
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I am able to get out of my bed or chair and move around.
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My testosterone level is below 50 ng/dL, and I am continuing hormone therapy unless I've had both testicles removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 (each cycle is 28 days) through pre-dosing cycle 2, approximately 1 month.
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 (each cycle is 28 days) through pre-dosing cycle 2, approximately 1 month. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose
Response

Side effects data

From 2021 Phase 2 trial • 24 Patients • NCT02631590
75%
Platelet count decreased
75%
Lymphocyte count decreased
71%
White blood cell decreased
71%
Fatigue
67%
Neutrophil count decreased
67%
Anemia
63%
Hypertension
54%
Hyperglycemia
50%
Nausea
46%
Lipase increased
46%
Diarrhea
46%
Anorexia
42%
Alanine aminotransferase increased
42%
Abdominal Pain
33%
Fever
29%
Hyponatremia
25%
Hyperkalemia
25%
Constipation
25%
Vomiting
25%
Weight loss
25%
Dehydration
25%
Hypotension
25%
Rash maculo-papular
21%
Serum amylase increased
21%
Aspartate aminotransferase increased
21%
Edema limbs
17%
Creatinine increased
17%
Alkaline phosphatase increased
17%
Sinus tachycardia
17%
Chills
17%
Pain
17%
Thromboembolic event
17%
Dizziness
13%
Generalized muscle weakness
13%
Pain in extremity
13%
Gastrointestinal disorders - Other
13%
Mucositis oral
13%
Anxiety
13%
Tinnitus
13%
Infusion related reaction
13%
Non-cardiac chest pain
13%
Blood bilirubin increased
13%
Hypoalbuminemia
13%
Dyspnea
13%
Sepsis
13%
Upper respiratory infection
13%
Urinary tract infection
8%
Back pain
8%
Neck pain
8%
Depression
8%
Gallbladder obstruction
8%
Abdominal distension
8%
Ascites
8%
Bloating
8%
Dysphagia
8%
General disorders and administration site conditions -Other
8%
Cough
8%
Hypoxia
8%
Pleural effusion
8%
Pruritus
8%
Rash acneiform
8%
Infections and infestations - Other
8%
Insomnia
8%
Dysgeusia
8%
Peripheral sensory neuropathy
4%
Sore throat
4%
Productive cough
4%
Cataract
4%
Lung infection
4%
Gastrointestinal disorders -Other
4%
Cholecystitis
4%
Infections and Infestations - Other
4%
Pancreatitis
4%
Toothache
4%
Stomach pain
4%
Postnasal drip
4%
Wheezing
4%
Hoarseness
4%
Hepatic infection
4%
Nasal congestion
4%
Pneumonitis
4%
Urinary tract obstruction
4%
Bone pain
4%
Musculoskeletal and connective tissue disorders - Other
4%
Gallbladder infection
4%
Paroxysmal atrial tachycardia
4%
Pericarditis
4%
Sinus bradycardia
4%
Ear pain
4%
Dry eye
4%
Fracture
4%
Neoplasms benign, malignant and unspecified - Other
4%
Colitis
4%
Colonic obstruction
4%
Dry mouth
4%
Gastroesophageal reflux disease
4%
Infusion site extravasation
4%
Malaise
4%
Activated partial thromboplastin time prolonged
4%
Blood antidiuretic hormone abnormal
4%
Investigations - Other
4%
Urine output decreased
4%
Hypercalcemia
4%
Hypernatremia
4%
Hyperuricemia
4%
Hypokalemia
4%
Hypomagnesemia
4%
Phlebitis
4%
Aspiration
4%
Atelectasis
4%
Epistaxis
4%
Hiccups
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Skin ulceration
4%
Confusion
4%
Acute kidney injury
4%
Cystitis noninfective
4%
Hematuria
4%
Renal and urinary disorders - Other
4%
Urine discoloration
4%
Injury, poisoning and procedural complications - Other
4%
Gait disturbance
4%
Headache
4%
Parathesia
4%
Venous injury
4%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose Level 4Experimental Treatment2 Interventions
600 mg Rucaparib, 60 mg Copanlisib
Group II: Dose Level 3Experimental Treatment2 Interventions
600 mg Rucaparib, 45 mg Copanlisib
Group III: Dose Level 2Experimental Treatment2 Interventions
500 mg Rucaparib, 45 mg Copanlisib
Group IV: Dose Level 1Experimental Treatment2 Interventions
400 mg Rucaparib, 45 mg Copanlisib
Group V: Dose Level -2Experimental Treatment2 Interventions
300 mg Rucaparib, 45 mg (day 1 & 15) Copanlisib
Group VI: Dose Level -1Experimental Treatment2 Interventions
400 mg Rucaparib, 45 mg (day 1 & 15) Copanlisib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rucaparib
2016
Completed Phase 3
~1990
Copanlisib
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
454 Previous Clinical Trials
562,798 Total Patients Enrolled
7 Trials studying Prostate Cancer
64 Patients Enrolled for Prostate Cancer
Rhode Island HospitalOTHER
260 Previous Clinical Trials
71,721 Total Patients Enrolled
2 Trials studying Prostate Cancer
17 Patients Enrolled for Prostate Cancer
The Miriam HospitalOTHER
238 Previous Clinical Trials
37,592 Total Patients Enrolled
4 Trials studying Prostate Cancer
68 Patients Enrolled for Prostate Cancer

Media Library

Copanlisib (PI3K inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04253262 — Phase 1 & 2
Prostate Cancer Research Study Groups: Dose Level -2, Dose Level -1, Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4
Prostate Cancer Clinical Trial 2023: Copanlisib Highlights & Side Effects. Trial Name: NCT04253262 — Phase 1 & 2
Copanlisib (PI3K inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04253262 — Phase 1 & 2

Frequently Asked Questions

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

Have investigators conducted any previous investigations with Copanlisib?

"Currently, 65 Copanlisib studies are underway, 8 of which are currently in Phase 3. These trials span 4354 locations with the majority based around Lexington, Kentucky."

Answered by AI

Are there any remaining openings to participate in this investigation?

"Clinicialtrials.gov has revealed that this medical experiment is enrolling individuals as of now. The initial posting was on April 3rd 2020 and the most recent edit occurred on July 27th 2022."

Answered by AI

Is this the initial experiment of its kind?

"Since 2012, Copanlisib has been subject to numerous clinical investigations. Initially developed by Bayer in a trial involving 227 participants, the drug eventually received its Phase 2 approval. Currently, 1187 cities across 48 nations are engaged in 65 active trials of this medication."

Answered by AI

To what extent is this clinical trial being populated by participants?

"Affirmative. Clinicaltrials.gov data attests that from April 3rd 2020, this clinical trial has been recruiting participants and editing details as recently as July 27th 2022. The study seeks 44 patients in total at 2 locations for participation."

Answered by AI
~3 spots leftby Apr 2025