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RECRUITING
NCT05064618
PHASE1/PHASE2

Investigator-initiated Clinical Trial of MIKE-1

Sponsor: Nagoya University

View on ClinicalTrials.gov

Summary

To evaluate the safety and tolerability of Am80(Generic name: Tamibarotene, Development code: MIKE-1) in combination with gemcitabine (GEM) and nab-paclitaxel (nab-PTX) in patients with unresectable pancreatic cancer and to determine the recommended dose. Efficacy will also be exploratively investigated.

Official title: Phase I/II Investigator-initiated Clinical Trial of MIKE-1 With Gemcitabine and Nab-paclitaxel Combination Therapy for Unresectable Pancreatic Cancer

Key Details

Gender

All

Age Range

20 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2021-08-23

Completion Date

2025-04-30

Last Updated

2024-04-04

Healthy Volunteers

No

Interventions

DRUG

Am80

medicine taken internally

DRUG

Gemcitabine

Administered intravenously at a dose of 1000mg/m2

DRUG

nab-Paclitaxel

Administered intravenously at a dose of 125mg/m2

Locations (2)

Nagoya University Hospital

Nagoya, Aich, Japan

The University of Tokyo Hospital

Tokyo, Japan