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Investigator-initiated Clinical Trial of MIKE-1

NCT05064618 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-04-04

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Japan Agency for Medical Research and Development

    collaborator OTHER_GOV

  • Nagoya University

    lead OTHER

Principal Investigators

  • Hiroki Kawashima · Nagoya University

  • Mitsuhiro Fujishiro · The University of Tokyo Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT05064618 on ClinicalTrials.gov