Your session is about to expire
← Back to Search
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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose
Side effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dizziness
22%
Insomnia
22%
Dyspnea
22%
Abdominal pain
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Sinus tachycardia
9%
Urinary tract infection
9%
Cough
9%
Dehydration
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Postnasal drip
4%
Hoarseness
4%
Hypotension
4%
Hot flashes
4%
Peripheral sensory neuropathy
4%
Hyperkalemia
4%
Head injury
4%
Hypokalemia
4%
Hyponatremia
4%
Flu like symptoms
4%
Skin tear
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Bruising
4%
Esophageal ulcer
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Oral petechia
4%
Edema limbs
4%
Upper respiratory infection
4%
Leukocytosis
4%
White blood cell decreased
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
Awards & Highlights
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.
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
13,925 Previous Clinical Trials
41,017,970 Total Patients Enrolled
1 Trials studying BRCA2 Mutation
18 Patients Enrolled for BRCA2 Mutation
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,214 Total Patients Enrolled
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.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger