8 Participants Needed

Niraparib for Soft Tissue Sarcoma

Recruiting at 7 trial locations
WT
ER
Sujana Movva, MD - MSK Sarcoma Medical ...
Overseen BySujana Movva, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
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

What is the purpose of this trial?

The purpose of this study is to test whether the study drug, niraparib, is effective against unresectable and/or metastatic soft tissue sarcoma with DDR mutations. The researchers will also study whether niraparib is safe and causes few or mild side effects, and whether there are groups of DDR mutations in soft tissue sarcoma cells that respond better to treatment with niraparib.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chemotherapy or investigational therapies, you must have completed them at least 4 weeks before starting the study drug. If you are on estrogen modulating therapies, you must have stopped them at least 2 weeks prior to the study drug administration.

How is the drug Niraparib different from other drugs for soft tissue sarcoma?

Niraparib is unique because it is a PARP inhibitor, which means it works by blocking a protein that helps repair DNA damage in cancer cells, potentially making it effective for certain cancers. This mechanism is different from other treatments like doxorubicin or pazopanib, which are more commonly used for soft tissue sarcomas and work through different pathways.12345

Research Team

ER

Evan Rosenbaum, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with certain types of soft tissue or uterine sarcoma that can't be surgically removed and have spread, who've tried at least one other cancer treatment. They must have specific genetic changes in their tumor DNA related to the DDR pathway, measurable disease, good organ function, and a performance status indicating they can care for themselves. Women must not be pregnant and agree to contraception; men also need to use birth control.

Inclusion Criteria

Participants or their legally authorized representatives (LARs) need to be willing to provide written informed consent/assent for the trial
Presence of measurable disease by RECIST 1.1
I practice abstinence as my form of birth control.
See 16 more

Exclusion Criteria

I am not allergic to the study drug or its ingredients.
I have been treated with a PARP inhibitor before.
Patient is simultaneously enrolled on any therapeutic clinical trial
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive niraparib to assess its effectiveness against unresectable and/or metastatic soft tissue sarcoma with DDR mutations

12 weeks
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Periodic visits for assessment of adverse events

Treatment Details

Interventions

  • Niraparib
Trial OverviewThe trial is testing Niraparib's effectiveness on advanced soft tissue sarcomas with DDR mutations. It aims to find out if it's safe with mild side effects and if some genetic alterations respond better than others. Participants will receive Niraparib as the study drug.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: NiraparibExperimental Treatment1 Intervention
This study will utilize Simon's two-stage design: 16 patients will be enrolled in the first portion of this study. If 4 or more patients are progression-free at 12 weeks, an additional 16 patients will be enrolled for a total of n = 32 patients enrolled.

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?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

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)
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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

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Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

References

[Medical treatment of soft tissue sarcomas based on the histological subtype]. [2014]
Pazopanib for metastatic soft-tissue sarcoma: A multicenter retrospective study. [2021]
Randomized Comparison of Pazopanib and Doxorubicin as First-Line Treatment in Patients With Metastatic Soft Tissue Sarcoma Age 60 Years or Older: Results of a German Intergroup Study. [2021]
Efficacy of pazopanib monotherapy in patients who had been heavily pretreated for metastatic soft tissue sarcoma: a retrospective case series. [2022]
Developments in Systemic Therapy for Soft Tissue and Bone Sarcomas. [2020]