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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 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.

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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.

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

FieldValue
Enrollment Target 15 participants
Start Date 2022-12-15
Est. Completion 2026-06
Phase Phase 1

Sponsor

Amr Mohamed MD

1 total trials

What the Registry Record Tells You About NCT05262556

The ClinicalTrials.gov registry entry for NCT05262556 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 280-participant average among 13 other Neuroendocrine Carcinoma trials with a reported enrollment target (95% lower). The listed sponsor is Amr Mohamed MD, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

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