40 Participants Needed

Genetic Profile-Guided Therapy for Ovarian Cancer

Stephanie Lheureux profile photo
Overseen ByStephanie Lheureux
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have taken an investigational drug (other than a PARP inhibitor) within 30 days or a PARP inhibitor within 14 days before starting the study treatment.

What data supports the effectiveness of the drug combination including Niraparib for ovarian cancer?

Research shows that Niraparib, a drug in the treatment plan, helps extend the time patients with ovarian cancer live without the disease getting worse, especially after initial chemotherapy. It is effective for patients with or without specific genetic mutations.12345

Is niraparib safe for use in humans?

Niraparib is generally well tolerated in humans, with the main safety concern being myelosuppression (a decrease in bone marrow activity leading to fewer blood cells). This side effect is manageable with monitoring and dose adjustments based on weight and platelet count.678910

How is the drug Niraparib unique in treating ovarian cancer?

Niraparib is unique because it is a PARP inhibitor that can be used as maintenance therapy for ovarian cancer patients who have responded to platinum-based chemotherapy, regardless of their BRCA mutation or homologous recombination deficiency status. This makes it a versatile option for patients with limited maintenance treatment choices.457811

What is the purpose of this trial?

The purpose of this research study is to see how useful it is to look at biomarkers in the blood and tumor tissue of participants with ovarian, fallopian tube or primary peritoneal cancer who have previously received treatment with a drug called a PARP inhibitor, and using the results to determine the best treatment for these participants. Biomarkers are molecules such as genes (molecules that contain instructions for the development and function of cells in the body) and proteins that may be used to see how well a body responds to certain treatments.

Research Team

Dr. Stéphanie Lheureux | Bras DDP

Stephanie Lheureux

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

This trial is for patients with ovarian, fallopian tube, or primary peritoneal cancer who have relapsed after PARP inhibitor therapy. They must have a good heart function, measurable disease by RECIST 1.1 criteria, and proper organ function. Women of childbearing potential need to use effective contraception and not breastfeed during the study.

Inclusion Criteria

I agree not to donate blood during and for 3 months after the study.
Patient must agree to not breastfeed during the study or for 30 days after the last dose of study treatment
My cancer has returned after treatment, regardless of how many treatments I've had.
See 10 more

Exclusion Criteria

I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
I have not had major chest or belly surgery in the last 2 weeks or any unhealed surgical cuts.
I don't have lasting side effects from cancer treatment worse than mild.
See 21 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biomarker Testing

Blood and tumor tissue samples are collected for biomarker testing to determine the participant's molecular profile

3 weeks
1 visit (in-person)

Initial Treatment

Participants receive bevacizumab and niraparib for 3 cycles, each cycle being 21 days

9 weeks
3 visits (in-person)

Cohort-Specific Treatment

Participants are assigned to a cohort based on genetic testing results and receive a combination of study drugs until disease progression or discontinuation criteria are met

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Bevacizumab
  • Dostarlimab
  • Niraparib
  • Paclitaxel
Trial Overview The trial tests if using genetic markers from blood and tumor tissue can guide treatment choices post-PARP inhibitors in cancers like ovarian cancer. It involves drugs Niraparib, Dostarlimab, Bevacizumab, Paclitaxel to see which works best based on these biomarkers.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Initial/Cohort CExperimental Treatment2 Interventions
Niraparib by mouth (orally), once a day, every day. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks.
Group II: Cohort BExperimental Treatment3 Interventions
Paclitaxel, by vein (intravenously), once a week. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks. Dostarlimab, by vein (intravenously), once every 3 weeks for 4 doses, then every 6 weeks afterwards.
Group III: Cohort AExperimental Treatment3 Interventions
Niraparib by mouth (orally), once a day, every day. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks. Dostarlimab, by vein (intravenously), once every 3 weeks for 4 doses, then every 6 weeks afterwards.

Niraparib is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Zejula for:
  • Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
  • Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
🇺🇸
Approved in United States as Zejula for:
  • Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
  • Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
🇨🇦
Approved in Canada as Zejula for:
  • Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

GlaxoSmithKline

Industry Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

In a phase 3 trial involving 733 patients with newly diagnosed advanced ovarian cancer, niraparib significantly improved progression-free survival compared to placebo, with a median of 21.9 months versus 10.4 months for patients with homologous-recombination deficiency.
Niraparib also demonstrated a notable overall survival rate of 84% at 24 months, with manageable side effects, including anemia and thrombocytopenia, but no treatment-related deaths, indicating its safety and efficacy as a treatment option.
Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.González-Martín, A., Pothuri, B., Vergote, I., et al.[2019]
In a study of 105 patients with newly diagnosed advanced ovarian cancer, the combination of niraparib and bevacizumab as first-line maintenance therapy resulted in a promising progression-free survival (PFS) rate of 62% at 18 months, with even higher rates in patients with homologous recombination deficiency (76%).
The safety profile of this combination therapy was consistent with the known side effects of the individual drugs, with common treatment-related adverse events including thrombocytopenia, fatigue, and anemia, indicating that the treatment is manageable for patients.
OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab.Hardesty, MM., Krivak, TC., Wright, GS., et al.[2022]
In a real-world study of 22 ovarian cancer patients treated with niraparib at a dose of 200 mg/day, the objective response rate was 33.3%, indicating promising efficacy, especially in patients with homologous recombination deficiency (HRD).
The most common adverse events included nausea, thrombocytopenia, and anemia, with severe thrombocytopenia managed through dose adjustments, suggesting that niraparib can be tolerated with appropriate monitoring and management.
The efficacy and safety of niraparib for ovarian cancer: a single-center observational study from China.Ni, J., Cheng, X., Zhao, Q., et al.[2021]

References

Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. [2019]
OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab. [2022]
The efficacy and safety of niraparib for ovarian cancer: a single-center observational study from China. [2021]
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. [2022]
Ad hoc Analysis of the Phase III ENGOT-OV16/NOVA Study: Niraparib Efficacy in Germline BRCA Wild-type Recurrent Ovarian Cancer with Homologous Recombination Repair Defects. [2023]
Niraparib for the treatment of ovarian cancer. [2019]
Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients. [2019]
Niraparib: A Review in First-Line Maintenance Therapy in Advanced Ovarian Cancer. [2022]
Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer. [2021]
Niraparib and Advanced Ovarian Cancer: A Beacon in the Non-BRCA Mutated Setting. [2023]
Niraparib: A Review in Ovarian Cancer. [2019]
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