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Heat Shock Factor 1 Pathway Inhibitor

NXP800 for Bile Duct Cancer

Phase 1

Recruiting

Led By Mitesh J. Borad, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Histologically/cytologically confirmed biliary tract cancer

Must not have

Major surgical procedure ≤ 28 days prior to registration

Presence of another primary malignancy not in remission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing the safety and effectiveness of a drug called NXP800 in treating patients with advanced or metastatic cholangiocarcinoma. NXP800 works by inhibiting a pathway called

Who is the study for?

This trial is for individuals with advanced or metastatic cholangiocarcinoma, which includes various types of bile duct cancer. Participants should have a form of the disease that has spread and are required to undergo specific imaging tests like PET scans, CT scans, MRIs, and biopsies.

What is being tested?

The trial is evaluating NXP800's safety and optimal dosage. NXP800 targets the HSF1 pathway involved in tumor growth and spread. The study will assess if inhibiting this pathway can reduce tumor activity in patients with advanced or metastatic cholangiocarcinoma.

What are the potential side effects?

While specific side effects for NXP800 are not listed here, common ones from drugs targeting pathways in cancer cells include nausea, fatigue, diarrhea, liver issues, skin reactions and potential impact on blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer diagnosis was confirmed through tissue examination.

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I am 18 years old or older.

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My advanced cancer did not respond to or I cannot tolerate gemcitabine or fluoropyrimidine treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 28 days.

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I have another type of cancer that is not currently in remission.

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I have severe heart failure.

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My brain cancer has not been controlled by treatment.

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I do not have any infections that aren't responding to treatment.

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I have no severe side effects from current treatments.

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I haven't had cancer treatment or radiation in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Recommended phase 2 dose

Secondary study objectives

Best response

Incidence of adverse events

Overall survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (NXP800)Experimental Treatment6 Interventions

Patients receive NXP800 according to assigned treatment schedule. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or PET at baseline and on study. Patients may optionally undergo ultrasound-guided liver biopsy and/or collection of blood samples on study and during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2740