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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.
For the Phase 1B components: Participant has histologically diagnosed gynecologic malignancy (i.e., any cancer that started in a woman's reproductive system). Gynecologic malignancies include cervical cancer; endometrial cancer; vaginal cancer; vulvar cancer; high-grade recurrent epithelial (i.e., serous, endometrioid, mucinous, clear cell) ovarian, fallopian tube, or primary peritoneal cancer; or advanced carcinosarcoma of the ovary. Participant with high-grade mixed histology is also eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

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 below
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I am a woman aged 18 or older and agree to participate in the study.
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I have a diagnosed cancer that started in my reproductive system.
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My white blood cell count is healthy without needing medication.
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I have been diagnosed with a specific type of gynecologic cancer.
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I have a high-grade cancer of the ovary, fallopian tube, or peritoneum.
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I am a woman over 18, understand the study, and agree to participate.
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I can provide enough tumor tissue samples as needed.
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I am able to care for myself and perform daily activities.
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My organs are functioning well.

OPAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

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 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
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%
Creatinine increased
17%
Platelet count decreased
17%
Mucositis oral
13%
Sinus tachycardia
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
9%
Back pain
9%
Urinary tract infection
9%
Dehydration
9%
Blood bilirubin increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
White blood cell decreased
4%
Lung infection
4%
Edema limbs
4%
Neutrophil count decreased
4%
Esophageal ulcer
4%
Depression
4%
Hyperkalemia
4%
Hypokalemia
4%
Sore throat
4%
Skin tear
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Leukocytosis
4%
Syncope
4%
Itchy eyes
4%
Hyponatremia
4%
Flu like symptoms
4%
Postnasal drip
4%
Hypotension
4%
Hoarseness
4%
Sinus pain
4%
Bloating
4%
Diarrhea
4%
Head injury
4%
Oral petechia
4%
Peripheral sensory neuropathy
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Upper respiratory infection
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
10,425 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,592 Previous Clinical Trials
6,138,065 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03574779 — Phase 1 & 2
Ovarian Tumors Research Study Groups: Cohort A: 1-2 prior lines of therapy (TSR-042, Bevacizumab, and Niraparib), Cohort C: Arm 1: Participants receiving platinum plus taxane, Cohort C: Arm 2: Participants receiving neoadjuvant Niraparib
Ovarian Tumors Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03574779 — Phase 1 & 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03574779 — Phase 1 & 2
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

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

What questions have other patients asked about this trial?

Basic questions like, how long are the trials?
PatientReceived 2+ prior treatments
~9 spots leftby Aug 2024