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Copanlisib + Rucaparib for Prostate Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 24 Patients • NCT02631590Trial Design
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Who is running the clinical trial?
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- 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.You are expected to live for at least three more months.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 am 18 years old or older.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.
- 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
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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