Niraparib for Ovarian Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ovarian TumorsNiraparib - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Ovarian Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 17 Secondary · Reporting Duration: Up to 6 years

Up to 12 months
Cohort C: PFS12
Up to 18 months
Cohort C: PFS18
Up to 24 months
Cohort C: PFS24
Up to 4 years
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)
Cohort A: Objective response rate
Cohort A: Overall survival (OS)
Cohort A: Progression free survival (PFS)
Cohort C: Number of participants with cancer antigen (CA)-125 progression
Cohort C: OS
Cohort C: PFS
Cohort C: Pre-IDS ORR
Cohort C: Time to first subsequent treatment (TFST)
Up to 6 years
Disease Control Rate (DCR)
Duration of Response (DOR)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Objective response rate
Overall survival (OS)
Progression free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
57%Nausea
52%Decreased appetite
48%Anaemia
48%Constipation
43%Fatigue
38%Dyspnoea
24%Oedema peripheral
24%Vomiting
24%Stomatitis
24%Platelet count decreased
19%Insomnia
19%Blood alkaline phosphatase increased
19%Arthralgia
19%Pruritus
14%Pneumonia
14%Diarrhoea
14%Cough
14%Pain
14%Chills
14%Upper respiratory tract infection
14%Weight decreased
14%Neutrophil count decreased
14%Dysgeusia
14%Back pain
14%Muscular weakness
10%Depression
10%Erythema
10%Vision blurred
10%Pleural effusion
10%Atrial fibrillation
10%Neuropathy peripheral
10%Haemorrhoids
10%Haemorrhoidal haemorrhage
10%Anxiety
10%Proctalgia
10%Oropharyngeal pain
10%Wheezing
10%Non-cardiac chest pain
10%Productive cough
10%Gait disturbance
10%Chest pain
10%Urinary tract infection
10%Hypophosphataemia
10%Aspartate aminotransferase increased
10%Dehydration
10%Blood creatinine increased
10%Hypokalaemia
10%Lymphocyte count decreased
10%Alanine aminotransferase increased
10%Rash maculo-papular
10%Pain of skin
10%Overdose
10%Hypothyroidism
5%Angina pectoris
5%Dizziness
5%Sepsis
5%Dysphonia
5%Sinus tachycardia
5%Neuroendocrine carcinoma of the skin
5%Gastrooesophageal reflux disease
5%Candida infection
5%Fall
5%Pulmonary embolism
5%Pneumonitis
5%Respiratory failure
5%Cardiac arrest
5%Pericardial effusion
5%Intestinal obstruction
5%Lactic acidosis
5%Diverticulitis
5%Lethargy
5%Headache
5%Cancer pain
5%Toxicity to various agents
5%Abdominal pain
5%Haematochezia
5%Nasal congestion
5%Asthenia
5%Pyrexia
5%Malaise
5%Hypomagnesaemia
5%Hyponatraemia
5%Amylase increased
5%Hepatic enzyme increased
5%Peripheral sensory neuropathy
5%Pain in extremity
5%Hyperhidrosis
5%Tachycardia
5%Contusion
5%Hypotension
5%Lipase increased
5%Syncope
5%Hyperglycaemia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03308942) in the Stage 1 (Cohort 2): Niraparib + Pembrolizumab ARM group. Side effects include: Nausea with 57%, Decreased appetite with 52%, Anaemia with 48%, Constipation with 48%, Fatigue with 43%.

Trial Design

4 Treatment Groups

Cohort C: Arm 1: Participants receiving platinum plus taxane
1 of 4
Cohort A: 1-2 prior lines of therapy
1 of 4
Cohort A: 1-2 prior lines of therapy (TSR-042, Bevacizumab, and Niraparib)
1 of 4
Cohort C: Arm 2: Participants receiving neoadjuvant Niraparib
1 of 4

Active Control

Experimental Treatment

125 Total Participants · 4 Treatment Groups

Primary Treatment: Niraparib · No Placebo Group · Phase 1 & 2

Cohort A: 1-2 prior lines of therapyExperimental Group · 3 Interventions: Niraparib, TSR-042, Bevacizumab · Intervention Types: Drug, Biological, Biological
Cohort A: 1-2 prior lines of therapy (TSR-042, Bevacizumab, and Niraparib)Experimental Group · 3 Interventions: Niraparib, TSR-042, Bevacizumab · Intervention Types: Drug, Biological, Biological
Cohort C: Arm 2: Participants receiving neoadjuvant NiraparibExperimental Group · 2 Interventions: Niraparib, Bevacizumab · Intervention Types: Drug, Biological
Cohort C: Arm 1: Participants receiving platinum plus taxaneActiveComparator Group · 4 Interventions: Niraparib, Bevacizumab, Carboplatin, Paclitaxel · Intervention Types: Drug, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved
Bevacizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 years

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor
55 Previous Clinical Trials
10,364 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,562 Previous Clinical Trials
6,133,480 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female greater than or equal to 18 years of age.
You have measurable disease according to RECIST version (v) 1.1.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Who else is applying?

What state do they live in?
California100.0%
What site did they apply to?
GSK Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
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."
What questions have other patients asked about this trial?
  • "Basic questions like, how long are the trials?"
How many prior treatments have patients received?
0100.0%