What side effects are associated with this type of intervention?

The most common treatments for ovarian tumors, particularly those involving PARP inhibitors like Niraparib, are associated with several side effects. Niraparib can cause hematologic toxicities such as anemia, thrombocytopenia, and neutropenia. Other side effects include fatigue, nausea, and hypertension. Chemotherapy agents like carboplatin and paclitaxel, often used in combination, can lead to neuropathy, alopecia, and gastrointestinal disturbances. Targeted therapies, such as bevacizumab, may result in hypertension, proteinuria, and increased risk of thromboembolic events. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several PARP inhibitors for the treatment of ovarian tumors. Niraparib, a PARP inhibitor, is approved for maintenance therapy in patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. Other PARP inhibitors include olaparib and rucaparib. Olaparib is approved for maintenance treatment in patients with BRCA-mutated advanced ovarian cancer after response to platinum-based chemotherapy, and rucaparib is approved for the treatment of patients with BRCA-mutated ovarian cancer who have been treated with two or more chemotherapies. These approvals highlight the role of PARP inhibitors in managing ovarian cancer, particularly in patients with specific genetic mutations or those who have responded to prior treatments.

What other types of research exist?

Promising alternatives to Niraparib for ovarian tumor patients include Olaparib and Rucaparib, both of which are PARP inhibitors with demonstrated efficacy in clinical trials. Additionally, combination therapies involving PARP inhibitors and other agents, such as Cediranib with Olaparib, have shown potential. Investigational treatments like heated intraperitoneal chemotherapy (HIPEC) and novel targeted therapies are also being explored.

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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).

Must not have

Participant has symptomatic uncontrolled brain or leptomeningeal metastases

Participant had major surgery within 4 weeks of starting the study or participant has not recovered from any effects of any major surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

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.

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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My white blood cell count is healthy without needing medication.

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I can provide enough tumor tissue samples as needed.

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I have a diagnosed cancer that started in my reproductive system.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have uncontrolled cancer spread to my brain or its coverings causing symptoms.

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I haven't had major surgery in the last 4 weeks or still recovering from one.

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I have a serious health condition that is not under control.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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%

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

Back pain

Alanine aminotransferase increased

Blood bilirubin increased

Non-cardiac chest pain

Anxiety

Dry mouth

Cough

Urinary tract infection

Hypertension

Dehydration

Hyperkalemia

Head injury

Bloating

Unknown infection

Hyponatremia

Syncope

Ascites

Hoarseness

Upper respiratory infection

Lung infection

Tremor

White blood cell decreased

Hypotension

Sinus pain

Diarrhea

Esophageal ulcer

Hypokalemia

Skin tear

Sore throat

Leukocytosis

Flu like symptoms

Neutrophil count decreased

Peripheral sensory neuropathy

Bruising

Postnasal drip

Hematuria

Depression

Edema limbs

Hot flashes

Oral petechia

Hyperglycemia

Itchy eyes

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian tumors include PARP inhibitors, chemotherapy, and angiogenesis inhibitors. PARP inhibitors, such as Niraparib, work by blocking the PARP enzyme, which helps repair DNA damage in cells. This is particularly effective in cancer cells with BRCA mutations, leading to cell death. Chemotherapy, using agents like carboplatin and paclitaxel, targets rapidly dividing cells, causing DNA damage and cell death. Angiogenesis inhibitors, such as bevacizumab, prevent the formation of new blood vessels that tumors need to grow. These treatments are crucial for ovarian tumor patients as they target different aspects of tumor growth and survival, improving treatment efficacy and patient outcomes.