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NCT05283226 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy
A Phase 2 study of Carcinoma and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, sponsored by NATCO Pharma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 13
- Study locations
NCT05283226: Recruiting Phase 2 study of Carcinoma and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, sponsored by NATCO Pharma.
NCT05283226 is a Phase 2 study of Carcinoma and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by NATCO Pharma. The registered enrollment target is 21 participants, below the 254-participant average among 29 other Carcinoma trials with a reported enrollment target (92% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05283226, a Phase 2 study of Carcinoma and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by NATCO Pharma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 13
- Study locations
Study Summary
This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design with historical control ORR of 30% and a target ORR of 50%.
Primary Outcome
Objective response in terms of CR/PR per RECIST v1.1
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG NRC-2694-A
Study Locations (13)
California
- Providence Medical Foundation -Fullerton - Fullerton
- Los Angeles Hematology Oncology Medical Group - Los Angeles
Florida
- Lynn Cancer Center - Boca Raton
- Miami Cancer Center - Miami
Maharashtra
- Daycare Angels under AOH - Mumbai
- Grant Medical Foundation Ruby Hall Clinic - Pune
Kentucky
- Norton Cancer Institute - Downtown - Louisville
Maryland
- University of Maryland Greenebaum Cancer Center - Baltimore
Missouri
- Washington University - Siteman Cancer Center - St Louis
New Hampshire
- Dartmouth Hitchcock Medical Center - Lebanon
Pennsylvania
- Salib Oncology - Easton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-09-30 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT05283226 shows while recruiting
NCT05283226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 254-participant average among 29 other Carcinoma trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Paclitaxel is the first listed.
NCT05283226 lists 13 locations in 10 states (California, Florida, Maharashtra).
Frequently Asked Questions
What is clinical trial NCT05283226 about?
NCT05283226 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy". This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design w...
What is the current status of trial NCT05283226?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2022-09-30. Estimated completion is 2027-06-30.
What conditions does trial NCT05283226 study?
This clinical trial studies the following conditions: Carcinoma, Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05283226?
The interventions under investigation include: Paclitaxel (DRUG), NRC-2694-A (DRUG).
Who is sponsoring clinical trial NCT05283226?
This trial is sponsored by NATCO Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05283226 being conducted?
This trial has 13 study locations across California, Florida, Kentucky, Maryland, Missouri. 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 NCT05283226's enrollment target sits among peer trials
21 26th of 29 higher than 3 of 29 other Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma 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.
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