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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

Must not have

Known brain or leptomeningeal metastasis

Inability to swallow medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or its coverings.

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I cannot swallow pills.

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I have a history of MDS or AML.

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I am not on drugs that could react badly with the study treatment.

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I have not had major surgery in the last 3 weeks.

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I have a heart condition that affects my daily life.

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I have a condition that affects how my body absorbs nutrients.

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I do not have a severe, uncontrolled infection.

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I have severe diarrhea that is not managed with oral treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Preliminary efficacy (objective response rate [ORR]) of niraparib and neratinib in patients with advanced solid tumors.

To assess the frequency of adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 16Eligibility criteria met