RecruitingPhase 1Phase 2NCT05064618

Investigator-initiated Clinical Trial of MIKE-1

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

Sponsor

Nagoya University

Enrollment

55 participants

Start Date

Aug 23, 2021

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

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.

Eligibility

Min Age: 20 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study tests MIKE-1, a new investigational drug, as a first-line treatment for unresectable (inoperable) pancreatic cancer. It is an early-phase trial evaluating the safety and effectiveness of this new agent. **You may be eligible if...** - You are aged 20–79 with inoperable pancreatic adenocarcinoma confirmed by biopsy or cytology - You have not received any prior treatment (chemotherapy, radiation, or surgery) for this cancer - You have at least one measurable tumor on CT scan - You are in good health (ECOG 0–1) and have adequate blood and organ function **You may NOT be eligible if...** - You have already been treated for this pancreatic cancer - You are expected to survive less than 12 weeks - You have poor performance status or organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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