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PI3K Inhibitor
Niraparib + Copanlisib for Gynecologic Cancers
Phase 1
Waitlist Available
Led By Shannon N Westin
Research Sponsored by M.D. Anderson Cancer Center
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 up to 4 weeks
Awards & highlights
Study Summary
This trial is studying the best dose and side effects of niraparib and copanlisib for treating patients with endometrial, ovarian, primary peritoneal, or fallopian tube cancer that has come back.
Who is the study for?
This trial is for patients with recurrent endometrial, ovarian, primary peritoneal, or fallopian tube cancer. Participants must have had any number of prior chemotherapies and a life expectancy of at least 3 months. They should be able to perform daily activities with little assistance (ECOG status 0-1), not be pregnant, use effective contraception, and meet certain health criteria.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Niraparib and Copanlisib. It aims to find the best dose while observing side effects in patients whose cancer has returned. These drugs are believed to block enzymes that tumor cells need for growth.See study design
What are the potential side effects?
Potential side effects include issues related to blocking cell growth which may affect normal cells as well as cancerous ones. This can lead to fatigue, digestive problems, changes in blood counts or liver function tests among others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
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
Side effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Back pain
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Flu like symptoms
4%
Leukocytosis
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Depression
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Hypokalemia
4%
Head injury
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (niraparib, copanlisib)Experimental Treatment2 Interventions
Patients receive niraparib PO daily on days 1-28 and copanlisib IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
FDA approved
Niraparib
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,458 Total Patients Enrolled
75 Trials studying Endometrial Cancer
73,374 Patients Enrolled for Endometrial Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,185 Total Patients Enrolled
22 Trials studying Endometrial Cancer
5,454 Patients Enrolled for Endometrial Cancer
Shannon N WestinPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
1,165 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have recently used other treatments or medical procedures.Certain medical conditions, infections, and immune system disorders.You have a specific type of cancer called carcinosarcoma in the endometrium.Your cancer has come back and can be treated with radiation or surgery to try to cure it.You have not already tried too many different chemotherapy treatments for your recurrent endometrial or ovarian cancer.You have a disease that can be measured or assessed using specific criteria.You are able to carry out all your normal activities without restriction (ECOG 0) or you are restricted in physically strenuous activity but can still carry out light work (ECOG 1).Women who can have babies need to have a negative pregnancy test.Certain blood, liver, kidney, and heart health requirements.You are expected to live for at least 3 more months.In the expansion phase, participants must have specific criteria for their cancer coming back after platinum treatment and must have measurable disease that can be biopsied.You are pregnant, breastfeeding, or have had a recent bone marrow or organ transplant.Your tumor cannot be easily reached for a biopsy during the expansion phase of the trial.You have been diagnosed with certain types of recurrent cancers in the uterus, ovaries, fallopian tubes, or peritoneum, and there are no more treatments that can cure the cancer.You have ovarian cancer that has come back and did not respond well to platinum-based chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (niraparib, copanlisib)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Niraparib for use?
"Given that this is a Phase 1 trial with limited data supporting efficacy and safety, Niraparib has been rated on the scale of 1 to 3 as a score of 1."
Answered by AI
Is this the inaugural attempt to undertake such a trial?
"Currently, Niraparib is the subject of 130 active clinical trials across 1232 cities and 54 countries. Since Bayer's 2012 Phase 2 trial involving 227 patients concluded its approval process, 36 additional experiments have been completed."
Answered by AI
What is the total recruitment count for this trial?
"Affirmative. Clinicaltrials.gov specifies that the trial is still offering recruitment for patients, with a start date of April 29th 2019 and an updated version posted on August 23rd 2022. 44 participants are needed from one medical facility for this clinical study."
Answered by AI
What additional testing has featured Niraparib as a subject?
"Currently, 130 clinical trials related to the use of Niraparib are active with 15 in Phase 3. Most are situated near Washington D.C., but there are nearly 5000 research sites conducting investigations involving this drug."
Answered by AI
Is this test still enrolling participants?
"Affirmative. According to the clinicaltrials.gov listing, this study is actively looking for participants and began accepting applications on April 29th 2019. The most recent edit was made on August 23rd 2022 with 44 patients being sought out from a single site."
Answered by AI
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