EfficacyPhase 2NCT06237205
Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency
A Phase 2 study testing Niraparib in people with Efficacy, run by Korea University Anam Hospital.
Trial summary
Investigational Products: Niraparib Period: 3 years after IRB/EC approval Indication: Adult patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair (HRR) or homologous… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Efficacy
- What is being tested?
- Niraparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2024to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who agreed to participate in the KOSMOS-II master observation study.
- 19 years of age or older on the day of signing informed consent.
- Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor.
- Has either known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally confirmed HRD based on whole-genome sequencing (WGS).
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Has measurable disease per RECIST v1.1 as assessed by the local site investigator.
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- Female participants of reproductive potential must agree to use contraception during the treatment period and for at least 6 months after the last dose. Male participants must agree to use contraception during the treatment period and for 90 days plus 5 X half-life after last dose.
- Has adequate organ function.
- Willing to provide biopsies from the tumor at screening to the central laboratory
Who cannot join
- Any previous exposure to PARP inhibitor
- Any other active malignancy or diagnosis of another malignancy within 2 years before study enrollment
- Has leptomeningeal metastases.
- Active central nervous system (CNS) lesions.
- Were resistant to prior platinum therapy (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor.
- Any cytotoxic chemotherapy from a previous treatment regimen within 14 days.
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- Has received prior endocrine therapy as cancer treatment within 2 weeks prior to administration of study intervention.
- Has received palliative radiotherapy encompassing >20% of the bone marrow within 1 week of the first dose of study treatment.
- Has an active infection requiring systemic therapy.
- Has hypertension that cannot be adequately controlled with medication.
- Has active tuberculosis.
- Has active infection such as hepatitis B, hepatitis C
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- 15) Impairment of gastrointestinal function or gastrointestinal disorders 16) Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of the Investigational product.
- 17) Patients who do not consent to adequate contraception throughout the study period.
- 18) Has a known hypersensitivity to the components of the investigational product or its analogs.
- 19) Since this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- 20) Since this drug contains Yellow No. 4 (Tartrazine), patients with a history of hypersensitivity or allergy to this ingredient.
- 21) Medical, psychiatric, cognitive, or other conditions that may interfere with the ability of the subject to understand the subject information, provide the informed consent, follow the protocol process, or complete the clinical trial.
- 22) The investigator judges that it is not appropriate to participate in this study for else reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency (GAUSS)
Investigational Products: Niraparib Period: 3 years after IRB/EC approval Indication: Adult patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair (HRR) or homologous recombination deficiency identified by whole genome sequencing
Read the detailed description
Objectives:
- Primary Objective
- Antitumor activity defined as objective response at ≥ 8 weeks or stable disease (SD) at ≥ 16 weeks from the time of enrollment.
- Secondary Objectives
- Overall Survival (OS)
- Progression-Free Survival (PFS)
- Objective Response Rate (ORR) by RECIST v1.1
- Duration of response (DOR)
- Quality of life (QOL) assessed by EORTC-QLQ-C30
- Adverse Event (AEs)
- Exploratory biomarker analyses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
a highly selective PARP1 and PARP2 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Niraparib | Experimental | Not described Receives: Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response after 8 weeks
Antitumor activity defined as objective response after 8 weeks
Measured: at 8 weeks after Cycle 1 Day 1(each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start27 Feb 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, Korean Cancer Study Group
- Responsible party
- Principal investigator, Lee, Soo Hyeon, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237205
- Sponsor's protocol ID
- GAUSS
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency (GAUSS)
- ClinicalTrials.gov ID
- NCT06237205
- Acronym / sponsor ID
- GAUSS
- Conditions
- Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Takeda, Korean Cancer Study Group
- Study start
- 27 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigational Products: Niraparib Period: 3 years after IRB/EC approval Indication: Adult patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair (HRR) or homologous recombination deficiency identified by whole genome sequencing
Detailed description
Objectives:
- Primary Objective
- Antitumor activity defined as objective response at ≥ 8 weeks or stable disease (SD) at ≥ 16 weeks from the time of enrollment.
- Secondary Objectives
- Overall Survival (OS)
- Progression-Free Survival (PFS)
- Objective Response Rate (ORR) by RECIST v1.1
- Duration of response (DOR)
- Quality of life (QOL) assessed by EORTC-QLQ-C30
- Adverse Event (AEs)
- Exploratory biomarker analyses
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib | Experimental | Drug: Niraparib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient who agreed to participate in the KOSMOS-II master observation study.
- 19 years of age or older on the day of signing informed consent.
- Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor.
- Has either known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally confirmed HRD based on whole-genome sequencing (WGS).
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (20 listed)
- Any previous exposure to PARP inhibitor
- Any other active malignancy or diagnosis of another malignancy within 2 years before study enrollment
- Has leptomeningeal metastases.
- Active central nervous system (CNS) lesions.
- Were resistant to prior platinum therapy (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nirapariba highly selective PARP1 and PARP2 inhibitor | Drug | Niraparib |
Primary outcome
objective response after 8 weeks
Time frame: at 8 weeks after Cycle 1 Day 1(each cycle is 28 days)
Antitumor activity defined as objective response after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niraparib in people with Efficacy, run by Korea University Anam Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact soohyeon lee, phd (+82-2-920-6078 ext. +82-2-920-6078, soohyeon_lee@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response after 8 weeks (time frame: at 8 weeks after Cycle 1 Day 1(each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.