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NCT06004661 · ClinicalTrials.gov registry record · Phase 2
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 9
- Study locations
NCT06004661: Recruiting Phase 2 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by Novartis Pharmaceuticals.
NCT06004661 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 20 participants, below the 412-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (95% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06004661, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) administered to participants with progressive PSMA-positive metastatic castration-resistant prostate cancer. The study will also characterize the risk of QT prolongation of AAA617 in this participant population.
Primary Outcome
The absorbed dose in kidneys and selected organs will be summarized with descriptive statistics.
Conditions Studied
Interventions
- DRUG AAA617
- DRUG 68Ga-PSMA-11
Study Locations (9)
Other
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Vandœuvre-lès-Nancy
- Novartis Investigative Site - Essen
- Novartis Investigative Site - München
- Novartis Investigative Site - Milan
- Novartis Investigative Site - Naples
New York
- Mount Sinai Hosp Med School - New York
Andalusia
- Novartis Investigative Site - Granada
Murcia
- Novartis Investigative Site - El Palmar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-04-04 |
| Est. Completion | 2026-06-17 |
| Phase | Phase 2 |
What NCT06004661 shows while recruiting
NCT06004661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 412-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer (mCRPC) appearing as the primary indexed condition, and to 2 interventions - of which AAA617 is the first listed.
NCT06004661 lists 9 locations in 4 states (Other, New York, Andalusia).
Frequently Asked Questions
What is clinical trial NCT06004661 about?
NCT06004661 is a clinical study titled "Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function". This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) administered to participants with progressive PSMA-positive metastatic castrat...
What is the current status of trial NCT06004661?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-04-04. Estimated completion is 2026-06-17.
What conditions does trial NCT06004661 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC).
What interventions are being tested in trial NCT06004661?
The interventions under investigation include: AAA617 (DRUG), 68Ga-PSMA-11 (DRUG).
Who is sponsoring clinical trial NCT06004661?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06004661 being conducted?
This trial has 9 study locations across New York, Andalusia, Murcia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06004661's enrollment target sits among peer trials
20 14th of 15 higher than 2 of 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer (mCRPC) 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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