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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)
Must not have
Previous or concurrent history of malignancies within 5 years
Clinically significant, uncontrolled heart disease and/or recent events
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
No Placebo-Only Group
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.
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.
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 belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer has worsened despite treatment with abiraterone, enzalutamide, or apalutamide.
Select...
My prostate cancer is worsening even though my testosterone is very low.
Select...
I agree to provide a sample of my tumor for testing.
Select...
My testosterone level is below 50 ng/dL, and I am on hormone therapy unless I've had both testicles removed.
Select...
I haven't had any prostate cancer treatments in the last 21 days or 5 half-lives.
Select...
My cancer has specific DNA repair gene mutations.
Select...
My prostate cancer is spreading and my testosterone is very low.
Select...
My prostate cancer diagnosis was confirmed through tissue examination.
Select...
My PSA levels have been rising, showing my prostate cancer is progressing.
Select...
I am 18 years old or older.
Select...
I am able to get out of my bed or chair and move around.
Select...
My testosterone level is below 50 ng/dL, and I am continuing hormone therapy unless I've had both testicles removed.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had cancer within the last 5 years.
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I do not have any serious heart conditions that are not under control.
Select...
I haven't had any blood clots in the last 6 months.
Select...
My HIV infection is not under control.
Select...
I do not have severe lung, kidney, or liver conditions.
Select...
I have been diagnosed with cardiomyopathy.
Select...
I have had myelodysplastic syndrome or acute myeloid leukemia.
Select...
I have high blood pressure that isn't well-controlled.
Select...
I have not had severe bleeding in the last 4 weeks.
Select...
I have not had a blood or platelet transfusion in the week before starting treatment.
Select...
I do not have a serious infection right now.
Select...
I have not had major surgery or a serious injury in the last 28 days.
Select...
I have hepatitis B or C.
Select...
I have had a bone marrow or organ transplant from another person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 (each cycle is 28 days) through pre-dosing cycle 2, approximately 1 month.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 (each cycle is 28 days) through pre-dosing cycle 2, approximately 1 month.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose
Response
Side effects data
From 2021 Phase 2 trial • 24 Patients • NCT0263159075%
Platelet count decreased
75%
Lymphocyte count decreased
71%
Fatigue
71%
White blood cell decreased
67%
Anemia
67%
Neutrophil count decreased
63%
Hypertension
54%
Hyperglycemia
50%
Nausea
46%
Diarrhea
46%
Lipase increased
46%
Anorexia
42%
Alanine aminotransferase increased
42%
Abdominal Pain
33%
Fever
29%
Hyponatremia
25%
Weight loss
25%
Dehydration
25%
Hyperkalemia
25%
Hypotension
25%
Vomiting
25%
Constipation
25%
Rash maculo-papular
21%
Edema limbs
21%
Aspartate aminotransferase increased
21%
Serum amylase increased
17%
Chills
17%
Pain
17%
Alkaline phosphatase increased
17%
Creatinine increased
17%
Thromboembolic event
17%
Sinus tachycardia
17%
Dizziness
13%
Generalized muscle weakness
13%
Dyspnea
13%
Pain in extremity
13%
Blood bilirubin increased
13%
Hypoalbuminemia
13%
Infusion related reaction
13%
Non-cardiac chest pain
13%
Gastrointestinal disorders - Other
13%
Mucositis oral
13%
Sepsis
13%
Upper respiratory infection
13%
Urinary tract infection
13%
Anxiety
13%
Tinnitus
8%
Back pain
8%
Pleural effusion
8%
Cough
8%
Hypoxia
8%
Ascites
8%
Neck pain
8%
Insomnia
8%
Gallbladder obstruction
8%
Bloating
8%
General disorders and administration site conditions -Other
8%
Abdominal distension
8%
Dysphagia
8%
Pruritus
8%
Rash acneiform
8%
Peripheral sensory neuropathy
8%
Infections and infestations - Other
8%
Dysgeusia
8%
Depression
4%
Phlebitis
4%
Neoplasms benign, malignant and unspecified - Other
4%
Colitis
4%
Colonic obstruction
4%
Gastrointestinal disorders -Other
4%
Cholecystitis
4%
Dry mouth
4%
Pancreatitis
4%
Stomach pain
4%
Toothache
4%
Gait disturbance
4%
Infusion site extravasation
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%
Aspiration
4%
Atelectasis
4%
Epistaxis
4%
Hiccups
4%
Hoarseness
4%
Nasal congestion
4%
Pneumonitis
4%
Postnasal drip
4%
Productive cough
4%
Sore throat
4%
Wheezing
4%
Bone pain
4%
Paroxysmal atrial tachycardia
4%
Pericarditis
4%
Confusion
4%
Acute kidney injury
4%
Ear pain
4%
Cataract
4%
Dry eye
4%
Fracture
4%
Injury, poisoning and procedural complications - Other
4%
Venous injury
4%
Allergic reaction
4%
Hepatic infection
4%
Infections and Infestations - Other
4%
Urinary tract obstruction
4%
Lung infection
4%
Gastroesophageal reflux disease
4%
Malaise
4%
Musculoskeletal and connective tissue disorders - Other
4%
Skin ulceration
4%
Headache
4%
Parathesia
4%
Gallbladder infection
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Sinus bradycardia
4%
Cystitis noninfective
4%
Hematuria
4%
Renal and urinary disorders - Other
4%
Urine discoloration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2020
Copanlisib
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Brown UniversityLead Sponsor
466 Previous Clinical Trials
698,974 Total Patients Enrolled
7 Trials studying Prostate Cancer
64 Patients Enrolled for Prostate Cancer
Rhode Island HospitalOTHER
264 Previous Clinical Trials
68,766 Total Patients Enrolled
2 Trials studying Prostate Cancer
17 Patients Enrolled for Prostate Cancer
The Miriam HospitalOTHER
245 Previous Clinical Trials
37,885 Total Patients Enrolled
4 Trials studying Prostate Cancer
68 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,275 Previous Clinical Trials
25,539,386 Total Patients Enrolled
45 Trials studying Prostate Cancer
26,975 Patients Enrolled for Prostate Cancer
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
11,018 Total Patients Enrolled
3 Trials studying Prostate Cancer
311 Patients Enrolled for Prostate Cancer
Benedito Carneiro, MD, MSPrincipal InvestigatorBrown University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on immunosuppressive therapy but take 10mg/day or less of prednisone.I can take care of myself and am up and about more than half of my waking hours.I have had cancer within the last 5 years.I haven't had radiotherapy or chemo/immunotherapy in the last 2 weeks.I am not on anti-arrhythmic drugs for heart rhythm problems, except for amiodarone or propafenone.My cancer has worsened despite treatment with abiraterone, enzalutamide, or apalutamide.My organs and bone marrow are functioning well.I do not have any serious heart conditions that are not under control.I haven't had any blood clots in the last 6 months.If you have measurable disease, it has progressed according to a specific medical standard called RECIST 1.1 criteria.My prostate cancer is worsening even though my testosterone is very low.You are expected to live for at least three more months.I agree to provide a sample of my tumor for testing.My HIV infection is not under control.I have confirmed prostate cancer, including if it has changed to a neuroendocrine type but not if it started as small cell cancer.I haven't had major surgery, radiation, or significant injury in the last month.I will use a condom with spermicide during sex for 6 months after treatment ends.I do not have severe lung, kidney, or liver conditions.I have been diagnosed with cardiomyopathy.My testosterone level is below 50 ng/dL, and I am on hormone therapy unless I've had both testicles removed.I am not taking any strong medications that affect liver enzymes.I haven't had any prostate cancer treatments in the last 21 days or 5 half-lives.My cancer has specific DNA repair gene mutations.You have a current addiction or any medical, psychological, or social condition that would make it difficult for you to participate in the trial or for the researchers to evaluate your results accurately.A bone scan shows at least two new areas that indicate the cancer has spread.I have not received myeloid growth factors in the last 14 days.I have had myelodysplastic syndrome or acute myeloid leukemia.I have high blood pressure that isn't well-controlled.I haven't had DNA-damaging chemotherapy or PARP inhibitors during phase 2.I have not had severe bleeding in the last 4 weeks.You have a serious mental illness or social situation that makes it difficult for you to follow the study requirements.My prostate cancer is spreading and my testosterone is very low.My prostate cancer diagnosis was confirmed through tissue examination.I have previously been treated with taxane, radium-223, or sipuleucel-T.My cancer can either be measured by tests or it cannot.I have not had a blood or platelet transfusion in the week before starting treatment.My PSA levels have been rising, showing my prostate cancer is progressing.I do not have a serious infection right now.I am 18 years old or older.My cancer can be either visible on scans or not.I have not had major surgery or a serious injury in the last 28 days.I am able to get out of my bed or chair and move around.I have hepatitis B or C.My testosterone level is below 50 ng/dL, and I am continuing hormone therapy unless I've had both testicles removed.My brain or spinal cord cancer hasn't been treated yet, or if treated, it's been stable for 4 weeks.You are allergic to the drugs being tested or their ingredients.I have had a bone marrow or organ transplant from another person.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level -2
- Group 2: Dose Level -1
- Group 3: Dose Level 1
- Group 4: Dose Level 2
- Group 5: Dose Level 3
- Group 6: Dose Level 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.