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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 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.

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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.

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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

FieldValue
Enrollment Target 20 participants
Start Date 2024-04-04
Est. Completion 2026-06-17
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT06004661

The ClinicalTrials.gov registry entry for NCT06004661 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (95% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.