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NCT04502602 · ClinicalTrials.gov registry record · Phase 1
Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer
A Phase 1 study of Ovarian Cancer and Advanced Solid Tumor, sponsored by Virginia Commonwealth University.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04502602: Active Phase 1 study of Ovarian Cancer and Advanced Solid Tumor, sponsored by Virginia Commonwealth University.
NCT04502602 is a Phase 1 study of Ovarian Cancer and Advanced Solid Tumor that is active but no longer recruiting, run by Virginia Commonwealth University. The registered enrollment target is 18 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04502602, a Phase 1 study of Ovarian Cancer and Advanced Solid Tumor, is active but no longer recruiting, sponsored by Virginia Commonwealth University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The RP2D will be identified during the phase 1 dose escalation portion of the study using a modified 3+3 design and evaluated in a phase 1b dose expansion cohort of up to 12 patients with platinum-resistant ovarian cancer.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-08-24 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 1 |
What the registry record for NCT04502602 still lists
NCT04502602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (98% lower).
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.
NCT04502602 reports a single indexed study location in Virginia.
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.
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).
Who is sponsoring clinical trial NCT04502602?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04502602's enrollment target sits among peer trials
18 291st of 322 higher than 26 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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