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Oral Paclitaxel for Patients with Advanced Solid Tumors

NCT06589401 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-09-19

No results posted yet for this study

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 MTD)and 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.

Conditions

Interventions

DRUG

INP12

Oral paclitaxel

Sponsors & Collaborators

  • InnoUp Farma S.L.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-10-31
Completion
2026-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06589401 on ClinicalTrials.gov