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Alkylating agents
Combination Therapy for Ovarian Cancer (OPAL Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Tesaro, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inclusion Criteria: - Participant must be female greater than or equal to (>=)18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.
Absolute neutrophil count >=1500 per microliter (/mcL), without growth factor support (granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administration is not permitted within 2 weeks prior to screening).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
OPAL Trial Summary
This trial will study the effectiveness of niraparib, either alone or in combination with other treatments, in women with ovarian, fallopian tube, or primary peritoneal cancer.
Who is the study for?
This trial is for women aged 18 or older with high-grade recurrent ovarian, fallopian tube, or primary peritoneal cancer. They must have measurable disease and be in good enough health to participate (ECOG status of 0-2). Pregnant or breastfeeding women can't join, and participants need adequate organ function and not be on certain medications.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of niraparib alone or combined with other treatments like TSR-042, Bevacizumab, Paclitaxel, Carboplatin in treating ovarian cancer. Cohort A focuses on those with recurrent cancer; Cohort C includes newly diagnosed patients.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, blood cell count changes leading to increased infection risk or bleeding problems. There may also be reactions related to infusions and potential liver issues.
OPAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 18 or older and agree to participate in the study.
Select...
My white blood cell count is healthy without needing medication.
Select...
I can provide enough tumor tissue samples as needed.
Select...
I have a diagnosed cancer that started in my reproductive system.
Select...
I am able to care for myself and perform daily activities.
OPAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort A: Objective response rate
Cohort C: Pre-IDS ORR
Secondary outcome measures
Cohort A: Disease Control Rate (DCR)
Cohort A: Duration of Response (DOR)
Cohort A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
+9 moreSide 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%
Abdominal pain
22%
Dyspnea
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%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
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%
Bruising
4%
Unknown infection
4%
Ascites
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%
Head injury
4%
Hypokalemia
4%
Hyperkalemia
4%
Postnasal drip
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
OPAL Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Cohort C: Arm 2: Participants receiving neoadjuvant NiraparibExperimental Treatment2 Interventions
Participants are expected to receive 1 run-in cycle (up to 5 weeks) of carboplatin-paclitaxel during pre-screening. After confirmation that the tumor is HRd, participants will be randomized to three 21-day cycles of neoadjuvant niraparib therapy. After IDS, all participants will receive up to three 21-day cycles of adjuvant platinum-taxane doublet chemotherapy (and optional bevacizumab for participants deemed high-risk; third cycle is optional) followed by niraparib (and optional bevacizumab or bevacizumab biosimilar for participants deemed high- risk) maintenance treatment.
Group II: Cohort A: 1-2 prior lines of therapy (TSR-042, Bevacizumab, and Niraparib)Experimental Treatment3 Interventions
PARP Inhibitor-Naive Platinum-Resistant Ovarian Cancer Treatment Cohort with TSR-042, Bevacizumab, and Niraparib. TSR-042 administered 500 milligrams (mg) on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning on Cycle 5 Day 1 until progressive disease (PD) or toxicity. Bevacizumab administered 15 milligram per kilogram (mg/kg) every 3 weeks for up to 15 months. Niraparib 200 or 300 mg per day until PD or toxicity.
Group III: Cohort C: Arm 1: Participants receiving platinum plus taxaneActive Control4 Interventions
Participants are expected to receive 1 run-in cycle (up to 5 weeks) of carboplatin-paclitaxel during pre-screening. After confirmation that the tumor is homologous recombination-deficient (HRd). Participants will then be randomized to three 21-day cycles of platinum-taxane doublet chemotherapy (carboplatin plus paclitaxane). After interval debulking surgery (IDS), all participants will receive up to three 21-day cycles of adjuvant platinum-taxane doublet chemotherapy (and optional bevacizumab for participants deemed high-risk; third cycle is optional) followed by niraparib (and optional bevacizumab or bevacizumab biosimilar for participants deemed high- risk) maintenance treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
10,431 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,805 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cancer treatment within the last 3 weeks.I have uncontrolled cancer spread to my brain or its coverings causing symptoms.I am a woman aged 18 or older and agree to participate in the study.My white blood cell count is healthy without needing medication.I haven't had major surgery in the last 4 weeks or still recovering from one.I have a serious health condition that is not under control.I have a high-grade type of ovarian, fallopian tube, or peritoneal cancer.I can provide enough tumor tissue samples as needed.I still have side effects from previous chemotherapy.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have a diagnosed cancer that started in my reproductive system.I have followed the specific treatment rules for my cancer type as outlined.I have another cancer that has worsened or needed treatment in the last 2 years.I am a woman over 18, understand the study, and agree to participate.I am able to care for myself and perform daily activities.My organs are functioning well.I don't have any health issues that would affect the study results or stop me from completing the treatment.I have active hepatitis B or C.I have been diagnosed with a specific type of gynecologic cancer.You must have a measurable tumor according to specific guidelines.My cancer can be measured by standard criteria.I have not received a live vaccine in the last 14 days.I have a high-grade cancer of the ovary, fallopian tube, or peritoneum.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: 1-2 prior lines of therapy (TSR-042, Bevacizumab, and Niraparib)
- Group 2: Cohort C: Arm 1: Participants receiving platinum plus taxane
- Group 3: Cohort C: Arm 2: Participants receiving neoadjuvant Niraparib
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.
Ovarian Tumors Patient Testimony for trial: Trial Name: NCT03574779 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are enrolled in this experiment at most?
"Yes, you can tell from the information on clinicaltrials.gov that this particular trial is still enrolling patients. The study was first announced on November 15th, 2018 and was updated most recently on September 23rd, 2022. In total, they need to recruit 125 individuals from 12 different locations."
Answered by AI
Is this clinical trial happening in more than one place within the city limits?
"Currently, there are 12 sites where patients can enroll in this study. Sioux Falls, Baltimore and Boston have locations, as well as 9 other places. When deciding whether or not to enroll, please consider the proximity of the site to your home to limit travel if you choose to participate."
Answered by AI
What are some of the ailments that Niraparib has been known to help with?
"Niraparib is most often used to treat cancer, but can also be helpful for patients with recurrent platinum sensitive primary peritoneal cancer, stage iv epithelial ovarian cancer following initial surgical resection, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
Are people still being signed up for this trial?
"Yes, this trial is still looking for patients. The information on clinicaltrials.gov shows that thetrial was first posted on 11/15/2018 and last updated on 9/23/2022. So far, 125 people have signed up across 12 different sites."
Answered by AI
Do we have any historical context for evaluating the efficacy of Niraparib?
"Niraparib was originally studied in 2004 at Memoral Sloan Kettering Basking Ridge. The total number of completed trials is currently 1596, with 480 active studies ongoing. A large concentration of these investigations are taking place in Sioux Falls, South dakota."
Answered by AI
What are the goals of this research?
"According to the sponsor of this clinical trial, Tesaro, Inc., the primary outcome being measured is objective response rate over a period of up to 6 years. Additionally, this study will observe and collect data points on secondary outcomes including progression free survival (PFS), disease control rate (DCR), and duration of response (DOR)."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Basic questions like, how long are the trials?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have tried 18 rounds of chemo and am still not sure if this is a curative treatment.
PatientReceived no prior treatments
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