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mTOR inhibitor
Niraparib + Everolimus for Ovarian Cancer
Phase 1
Waitlist Available
Led By Casey Williams
Research Sponsored by Avera McKennan Hospital & University Health Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be ≥18 years of age
Patients with ovarian cancer must have had appropriate surgical management for their disease and should be platinum resistant (recurrence within 6 months of last platinum-containing regimen) or be refractory to platinum-containing regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the completion of 2 cycles (56 days +/- 7 days) patients will be assessed for disease response utilizing the same analysis that was used at baseline and then again at 16 weeks (112 days +/- 7 days) if the patient has stable disease or better.
Awards & highlights
Study Summary
This trial looks at combining two drugs to treat ovarian and breast cancer. The goal is to see if the combination is feasible and tolerated by patients.
Who is the study for?
Adults with advanced ovarian or breast cancer (except HER2+), resistant to standard treatments, can join. They must have a performance status ≤2, meaning they're able to walk and care for themselves. Participants need good organ function and agree to use birth control. Those with certain health conditions, recent major surgery, other cancers within 2 years, or known allergies to trial drugs cannot participate.Check my eligibility
What is being tested?
The study tests the combination of niraparib (a PARP inhibitor) and everolimus (an mTOR inhibitor) in patients with advanced gynecologic malignancies including ovarian and breast cancer. It's an open-label cohort study where all participants receive both drugs daily or thrice weekly for one cycle of 28 days.See study design
What are the potential side effects?
Potential side effects include blood disorders like low platelet/neutrophil counts, fatigue, kidney/liver function changes, allergic reactions to drug components, risk of infection due to immunosuppression from everolimus and possible development of myelodysplastic syndrome or acute myeloid leukemia from niraparib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My ovarian cancer is resistant to platinum-based treatments, and I've had surgery for it.
Select...
My blood tests show my organs are working well.
Select...
I have advanced gynecologic cancer and have tried or can't undergo all proven treatments.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am a woman who can have children and my pregnancy test was negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after the completion of 2 cycles (56 days +/- 7 days) patients will be assessed for disease response utilizing the same analysis that was used at baseline and then again at 16 weeks (112 days +/- 7 days) if the patient has stable disease or better.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the completion of 2 cycles (56 days +/- 7 days) patients will be assessed for disease response utilizing the same analysis that was used at baseline and then again at 16 weeks (112 days +/- 7 days) if the patient has stable disease or better.
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
Secondary outcome measures
Assess the toxicity of the combination of niraparib and everolimus in each cohort by number of participants with treatment related adverse events as assessed by CTCAE v4.03
Response rate
Other outcome measures
Symptom occurrence as measured by the Health Related Quality of Life (HRQOL) - Linear Analogue Self Assessment (LASA)
Symptom occurrence as measured by the Therapy Related Symptoms Checklist (TRSC)
Symptom severity as measured by the Health Related Quality of Life (HRQOL) - Linear Analogue Self Assessment (LASA)
+2 moreSide effects data
From 2021 Phase 1 & 2 trial • 122 Patients • NCT0265788971%
Anaemia
71%
Constipation
57%
Fatigue
57%
Hyponatraemia
57%
Vomiting
57%
Nausea
43%
Hypomagnesaemia
43%
Abdominal distension
43%
Abdominal pain
43%
Oedema peripheral
43%
Dyspnoea
43%
Hypoalbuminaemia
43%
Hypokalaemia
29%
Tachycardia
29%
Decreased appetite
29%
Headache
29%
Oropharyngeal pain
29%
Insomnia
29%
Hypothyroidism
29%
Diarrhoea
29%
Blood alkaline phosphatase increased
29%
Dizziness
14%
Back pain
14%
Pneumonia aspiration
14%
Pneumonitis
14%
Thrombocytopenia
14%
Anemia
14%
Ascites
14%
Obstruction gastric
14%
Small intestinal obstruction
14%
Procedural pneumothorax
14%
Pulmonary embolism
14%
Lymphopenia
14%
Neutropenia
14%
Abdominal pain upper
14%
Dry mouth
14%
Dyspepsia
14%
Gastrooesophageal reflux disease
14%
Stomatitis
14%
Blood alkaline phosphatase decreased
14%
Hypoxia
14%
Pleural effusion
14%
Pleuritic pain
14%
Upper-airway cough syndrome
14%
Night sweats
14%
Photosensitivity reaction
14%
Rash
14%
Dyspnoea exertional
14%
White blood cell count decreased
14%
Dehydration
14%
Hypocalcaemia
14%
Depression
14%
Cough
14%
Colitis
14%
Cholecystitis
14%
Hyperglycaemia
14%
Mental status changes
14%
Embolism
14%
Leukocytosis
14%
Conjunctivitis
14%
Aspartate aminotransferase increased
14%
Dysgeusia
14%
Confusional state
14%
Haematuria
14%
Proteinuria
14%
Pelvic pain
14%
Malignant pleural effusion
14%
Lymphocyte count decreased
14%
Weight decreased
14%
Arthralgia
14%
Pain in extremity
14%
Ataxia
14%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Niraparib 200 mg + Pembrolizumab
Phase 1: Niraparib 300 mg + Pembrolizumab
Phase 2 OC: Niraparib 200 mg + Pembrolizumab
Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
(each cycle is 28 days long) Everolimus 5 mg daily Niraparib 300 mg daily
Group II: Cohort 3Experimental Treatment2 Interventions
(each cycle is 28 days long) Everolimus 5 mg daily Niraparib 200 mg daily
Group III: Cohort 2Experimental Treatment2 Interventions
(each cycle is 28 days long) Everolimus 5 mg daily on Mondays, Wednesdays, and Fridays Niraparib 200 mg daily
Group IV: Cohort 1Experimental Treatment2 Interventions
(each cycle is 28 days long) Everolimus 5mg daily on Mondays, Wednesdays, and Fridays Niraparib 100mg daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved
Everolimus
FDA approved
Find a Location
Who is running the clinical trial?
Avera McKennan Hospital & University Health CenterLead Sponsor
34 Previous Clinical Trials
29,163 Total Patients Enrolled
3 Trials studying Breast Cancer
25,130 Patients Enrolled for Breast Cancer
Casey WilliamsPrincipal InvestigatorAvera Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I agree to use birth control from the start of the study for at least 180 days after the last dose.I have not had radiation on more than 20% of my bone marrow.I haven't had major surgery in the last 3 weeks and have recovered from any past surgeries.I haven't had severe blood-related side effects or extreme tiredness from cancer treatment for more than 4 weeks.My ovarian cancer is resistant to platinum-based treatments, and I've had surgery for it.I am not allergic to niraparib, everolimus, rapamycin, or their ingredients.I am not immunocompromised, but I may have had my spleen removed.I don't have any health issues that would affect the study or stop me from fully participating.I have never been treated with or participated in a study involving PARP inhibitors.My blood tests show my organs are working well.I am currently taking ACE inhibitors.I have advanced gynecologic cancer and have tried or can't undergo all proven treatments.My breast or gynecologic cancer is not responding to current treatments.I can take care of myself and am up and about more than half of my waking hours.I am a woman who can have children and my pregnancy test was negative.I agree to use birth control before, during, and for 6 months after the study.I haven't been treated for any cancer other than skin cancer in the last 2 years.I don't have lasting side effects from cancer treatment worse than Grade 2.I haven't had a blood transfusion in the last 4 weeks.My blood pressure is not well controlled.My breast cancer is HER2 positive based on standard tests.I am not on strong or moderate drugs that affect drug metabolism.I do not have any serious, uncontrolled health issues or infections.My breast cancer can be measured by standard criteria, or I have ovarian cancer which may or may not be measurable.I do not have brain or spinal cord cancer spread.I have never been diagnosed with MDS or AML.I am not pregnant, breastfeeding, or planning to become pregnant during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 4
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 10 Other Conditions - This treatment demonstrated efficacy for 10 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.
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