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NCT05997056 · ClinicalTrials.gov registry record · Phase 2
Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors
A Phase 2 study of Neuroendocrine Tumors and Pancreatic Neuroendocrine Tumor, sponsored by Aadi Bioscience.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 4
- Study locations
NCT05997056: Recruiting Phase 2 study of Neuroendocrine Tumors and Pancreatic Neuroendocrine Tumor, sponsored by Aadi Bioscience.
NCT05997056 is a Phase 2 study of Neuroendocrine Tumors and Pancreatic Neuroendocrine Tumor that is actively recruiting participants, run by Aadi Bioscience. The registered enrollment target is 21 participants, below the 179-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05997056, a Phase 2 study of Neuroendocrine Tumors and Pancreatic Neuroendocrine Tumor, is actively recruiting participants, sponsored by Aadi Bioscience.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 4
- Study locations
Study Summary
A Phase 2 multi-center, open-label, single arm study of nab-sirolimus in patients with well-differentiated neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, or pancreas who have not received prior treatment with mTOR inhibitors
Primary Outcome
Objective Response Rate (ORR) is defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, o
Conditions Studied
Interventions
- DRUG nab-sirolimus
Study Locations (4)
California
- Hoag Memorial Hospital Presbyterian - Newport Beach
Colorado
- Rocky Mountain Cancer Centers - Denver
Texas
- Texas Oncology - Dallas
Wisconsin
- Medical College of Wisconsin Cancer Center - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-11-07 |
| Est. Completion | 2025-12-08 |
| Phase | Phase 2 |
What NCT05997056 shows while recruiting
NCT05997056 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 179-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (88% lower).
The record links to 5 conditions, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 1 intervention - of which nab-sirolimus is the first listed.
NCT05997056 reports a single indexed study location in California, Colorado, Texas.
Frequently Asked Questions
What is clinical trial NCT05997056 about?
NCT05997056 is a clinical study titled "Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors". A Phase 2 multi-center, open-label, single arm study of nab-sirolimus in patients with well-differentiated neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, or pancreas who have not received prior treatment with mTOR inhibitors
What is the current status of trial NCT05997056?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2023-11-07. Estimated completion is 2025-12-08.
What conditions does trial NCT05997056 study?
This clinical trial studies the following conditions: Neuroendocrine Tumors, Pancreatic Neuroendocrine Tumor, NET, Gastrointestinal Neuroendocrine Tumor, Pulmonary Neuroendocrine Tumor.
What interventions are being tested in trial NCT05997056?
The interventions under investigation include: nab-sirolimus (DRUG).
Who is sponsoring clinical trial NCT05997056?
This trial is sponsored by Aadi Bioscience, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05997056 being conducted?
This trial has 4 study locations across California, Colorado, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05997056's enrollment target sits among peer trials
21 43rd of 52 higher than 9 of 52 other Neuroendocrine Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine Tumors 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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