Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589401
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-06-05
Brief Title:
Oral Paclitaxel for Patients with Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Trial Evaluating the Safety Tolerability and Pharmacokinetic Profile of INP12 in Patients with Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial evaluating the safety tolerability and pharmacokinetic profile of INP12 a nanoparticles-based oral paclitaxel in patients with advanced solid tumors
The aim in Part A Escalation phase is to determine the maximum tolerated dose MTD or the highest protocol-defined dose in the absence of exceeding the MTDand the recommended phase II dose RP2D of INP12 administered orally once a week during three consecutive weeks under a 28-day cycle in patients with advanced solid tumors
The aim in Part B Expansion phase is to assess the safety and tolerability of INP12 as monotherapy at the RP2D or highest protocol-defined dose in patients with selected advanced solid tumors
The aim in Part A Escalation phase is to determine the maximum tolerated dose MTD or the highest protocol-defined dose in the absence of exceeding the MTDand the recommended phase II dose RP2D of INP12 administered orally once a week during three consecutive weeks under a 28-day cycle in patients with advanced solid tumors
The aim in Part B Expansion phase is to assess the safety and tolerability of INP12 as monotherapy at the RP2D or highest protocol-defined dose in patients with selected advanced solid tumors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None