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ACTIVE NOT RECRUITING Phase 1

Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer

NCT04502602 · View on ClinicalTrials.gov ↗

Study Summary

To determine the recommended phase 2 dose (RP2D) of niraparib and neratinib in combination in patients with advanced solid tumors during Phase 1. To evaluate clinical benefit (≥4-month progression-free survival \[PFS\]) of niraparib and neratinib in patients with platinum-resistant ovarian cancer in Phase 1b.

Interventions

  • DRUG Neratinib 160 mg
  • DRUG Neratinib 200 mg
  • DRUG Neratinib 240 mg
  • DRUG Niraparib 100 mg
  • DRUG Niraparib 200 mg

Study Locations (1)

Virginia

  • Virginia Commonwealth University — Richmond

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2020-08-24
Est. Completion 2029-05-31
Phase Phase 1

Sponsor

Virginia Commonwealth University

513 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04502602

The ClinicalTrials.gov registry entry for NCT04502602 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 513 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions — of which Neratinib 160 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04502602 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04502602 about?

NCT04502602 is a clinical study titled "Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer". To determine the recommended phase 2 dose (RP2D) of niraparib and neratinib in combination in patients with advanced solid tumors during Phase 1. To evaluate clinical benefit (≥4-month progression-free survival \[PFS\]) of niraparib and neratinib in patients with platinum-resistant ovarian cancer in...

What is the current status of trial NCT04502602?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-08-24. Estimated completion is 2029-05-31.

What conditions does trial NCT04502602 study?

This clinical trial studies the following conditions: Ovarian Cancer, Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04502602?

The interventions under investigation include: Neratinib 160 mg (DRUG), Neratinib 200 mg (DRUG), Neratinib 240 mg (DRUG), Niraparib 100 mg (DRUG), Niraparib 200 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04502602?

This trial is sponsored by Virginia Commonwealth University, which has 513 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04502602 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial