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Tyrosine Kinase Inhibitor

Niraparib + Neratinib for Ovarian Cancer (iNNOVATE Trial)

Phase 1
Recruiting
Led By Sarah Gordon, DO
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Patients with advanced solid tumors, excluding primary CNS and prostate tumors, that have progressed during or after treatment with approved therapies or for which there is no standard effective therapy available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

iNNOVATE Trial Summary

This trial is testing a combination of two drugs to see what dose is effective and if the combination has any clinical benefits for patients with advanced solid tumors, specifically platinum-resistant ovarian cancer.

Who is the study for?
Adults with advanced solid tumors, including ovarian cancer patients who are platinum-resistant and have had at least two prior therapies but no BRCA mutation. Participants must have adequate organ function, not be pregnant or breastfeeding, agree to use contraception, and cannot have certain health conditions like uncontrolled infections or recent major surgeries.Check my eligibility
What is being tested?
The trial is testing different doses of Niraparib and Neratinib to find the safest and most effective combination for treating advanced solid tumors. The focus is on determining the best dose during Phase 1 and assessing benefits in ovarian cancer patients during Phase 1b.See study design
What are the potential side effects?
Potential side effects may include digestive issues such as diarrhea that could lead to dehydration, blood cell count changes affecting bone marrow function, liver problems indicated by altered enzyme levels, fatigue due to anemia (low hemoglobin), and possible allergic reactions.

iNNOVATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My advanced cancer, not in the brain or prostate, has worsened despite treatment.
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My kidney function is within the required range.
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My liver tests are within normal limits.
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I am fully active or can carry out light work.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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I am a woman with ovarian cancer that didn't respond to platinum therapy and have had 2 treatments without a BRCA mutation.

iNNOVATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Phase 1: To determine the Recommended phase 2 dose (RP2D) of niraparib and neratinib in patients with advanced solid tumors
Phase 1b: To evaluate clinical benefit (≥4-month progression-free survival [PFS]) of niraparib and neratinib in patients with platinum-resistant ovarian cancer.
Secondary outcome measures
Preliminary efficacy (objective response rate [ORR]) of niraparib and neratinib in patients with advanced solid tumors.
To assess the frequency of adverse events (AEs)

iNNOVATE Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 1b: Platinum Resistant Expansion CohortExperimental Treatment2 Interventions
This portion of the study provides for cohort expansion to observe for 4 month or greater progression-free survival in patients with platinum resistant ovarian cancer treated at the recommended phase 2 dose (RP2D) determined in Phase I.
Group II: Dose Level 4Experimental Treatment2 Interventions
Neratinib 240 mg and Niraparib 300 mg by mouth once daily for 28 day cycles.
Group III: Dose Level 3Experimental Treatment2 Interventions
Neratinib 240 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.
Group IV: Dose Level 2Experimental Treatment2 Interventions
Neratinib 200 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.
Group V: Dose Level 1Experimental Treatment2 Interventions
Neratinib 160 mg and Niraparib 200 mg by mouth once daily for 28 day cycles.
Group VI: Dose Level -1Experimental Treatment2 Interventions
Neratinib 160 mg and Niraparib 100 mg by mouth once daily for 28 day cycles.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,885,000 Total Patients Enrolled
Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
9,897 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,771 Total Patients Enrolled

Media Library

Neratinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04502602 — Phase 1
Solid Tumors Research Study Groups: Dose Level 4, Phase 1b: Platinum Resistant Expansion Cohort, Dose Level -1, Dose Level 1, Dose Level 2, Dose Level 3
Solid Tumors Clinical Trial 2023: Neratinib Highlights & Side Effects. Trial Name: NCT04502602 — Phase 1
Neratinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502602 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Neratinib commonly prescribed to treat at its recommended dosage?

"Neratinib can be used to manage the progression of neoplasms such as fallopian tube cancer, carcinoma and breast cancer at its recommended phase 2 dose."

Answered by AI

Is this project actively seeking participants?

"Affirmative. According to clinicaltrials.gov's records, this study is actively looking for participants - the initial post was on August 24th 2020 and there was a recent update on November 3rd 2022. Currently, 45 patients need to be recruited at one site."

Answered by AI

Has Neratinib been tested at a Recommended Phase 2 Dose previously?

"Currently, there are 118 live trials studying the effectiveness of Neratinib at RP2D with 13 studies in Phase 3. Washington DC is a major centre for these clinical research efforts, but there are also 2946 other sites worldwide conducting similar investigations."

Answered by AI

Approximately how many participants are receiving treatment in this research project?

"Affirmative, the clinicaltrials.gov website confirms that this trial is actively recruiting subjects. The initial announcement was published on August 24th 2020 and updated recently on November 3rd 2022. 45 participants are needed between 1 location for the medical research to be successful."

Answered by AI

Has the Food and Drug Administration approved Neratinib for use at its recommended dosage?

"Our team at Power has assigned Neratinib a score of 1 in terms of safety when dosed at the Recommended Phase 2 Dose, as this is an early-stage trial with limited evidence supporting both efficacy and safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer
2020. "Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04502602.
~1 spots leftby May 2024
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