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NCT05262556 · ClinicalTrials.gov registry record · Phase 1
NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas
A Phase 1 study of Neuroendocrine Carcinoma and Gastroenteropancreatic Neuroendocrine Tumor, sponsored by Amr Mohamed MD.
- Active
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05262556: Active Phase 1 study of Neuroendocrine Carcinoma and Gastroenteropancreatic Neuroendocrine Tumor, sponsored by Amr Mohamed MD.
NCT05262556 is a Phase 1 study of Neuroendocrine Carcinoma and Gastroenteropancreatic Neuroendocrine Tumor that is active but no longer recruiting, run by Amr Mohamed MD. The registered enrollment target is 15 participants, below the 280-participant average among 13 other Neuroendocrine Carcinoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05262556, a Phase 1 study of Neuroendocrine Carcinoma and Gastroenteropancreatic Neuroendocrine Tumor, is active but no longer recruiting, sponsored by Amr Mohamed MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
A pilot study to evaluate the anti-tumor efficacy of this novel combined regimen (NP-101 TQ Formula plus nivolumab and ipilimumab) in the second-line setting for EP-NECA. NP-101 (TQ Formula) (TQ, C10H12O2) is the main bioactive component of the black seed (Nigella sativa, Ranunculaceae family) and has anti-oxidant, anti-angiogenic effects.
Primary Outcome
Antitumor activity will be measured by the number of participants that have a complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response is first met. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter. SD is defined as neither sufficient decreas
Conditions Studied
Interventions
- DRUG NP-101 (TQ Formula)
- DRUG Nivolumab (3mg/kg)
- DRUG Ipilimumab (1mg/kg)
Study Locations (1)
Ohio
- University hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What the registry record for NCT05262556 still lists
NCT05262556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 280-participant average among 13 other Neuroendocrine Carcinoma trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Neuroendocrine Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which NP-101 (TQ Formula) is the first listed.
NCT05262556 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05262556 about?
NCT05262556 is a clinical study titled "NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas". A pilot study to evaluate the anti-tumor efficacy of this novel combined regimen (NP-101 TQ Formula plus nivolumab and ipilimumab) in the second-line setting for EP-NECA. NP-101 (TQ Formula) (TQ, C10H12O2) is the main bioactive component of the black seed (Nigella sativa, Ranunculaceae family) and h...
What is the current status of trial NCT05262556?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-12-15. Estimated completion is 2026-06.
What conditions does trial NCT05262556 study?
This clinical trial studies the following conditions: Neuroendocrine Carcinoma, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Neoplasm, Mixed Neuroendocrine-Non Neuroendocrine Neoplasm.
What interventions are being tested in trial NCT05262556?
The interventions under investigation include: NP-101 (TQ Formula) (DRUG), Nivolumab (3mg/kg) (DRUG), Ipilimumab (1mg/kg) (DRUG).
Who is sponsoring clinical trial NCT05262556?
This trial is sponsored by Amr Mohamed MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05262556 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05262556's enrollment target sits among peer trials
15 14th of 13 the lowest of 13 other Neuroendocrine Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine 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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