Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 1:49 PM
Study NCT ID:
NCT03308604
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2017-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy
Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Organization:
Study Overview
Official Title:
Phase I Study of AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NANOCOL
Brief Summary:
This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method.
Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).
Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016/2508 | OTHER | CSET number | View |