TERMINATED

NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma

Conditions

Advanced Cholangiocarcinoma Metastatic Cholangiocarcinoma Refractory Cholangiocarcinoma Stage III Hilar Cholangiocarcinoma AJCC v8 Stage III Intrahepatic Cholangiocarcinoma AJCC v8 Stage IV Hilar Cholangiocarcinoma AJCC v8 Stage IV Intrahepatic Cholangiocarcinoma AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I trial tests the safety, best dose, and effectiveness of NXP800 in treating patients with cholangiocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). NXP800 inhibits a pathway called the heat shock factor 1 (HSF1) pathway. The inhibition of this pathway inhibits proliferation, migration, survival, and metastasis in susceptible tumor cells. Overexpressed, amplified and/or overactivated in many cancer cells, HSF1 activates a set of genes that play a key role in tumor initiation, progression and metastasis. Inhibiting this pathway may in turn inhibit tumor initiation, progression, and/or metastasis. Giving NXP800 may be safe, tolerable and/or effective in treating patients with advanced or metastatic cholangiocarcinoma.

Official Title

Phase 1b Study of the Novel GCN2 Kinase Activator NXP800 in Patients With Advanced Cholangiocarcionoma

Quick Facts

Study Start:2024-05-31

Study Completion:2025-09-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06420349

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years * Histologically/cytologically confirmed biliary tract cancer * Advanced or metastatic disease that is refractory to gemcitabine or fluoropyrimidine based therapy, or if there is intolerance to these regimens * Measurable disease by RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Anticipated life expectancy of \> 12 weeks * Hemoglobin ≥ 9.0 g/dL (obtained ≤ 14 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 14 days prior to registration) * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 14 days prior to registration) * Aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration) * Alanine aminotransferase (ALT) ≤ 5 x ULN (obtained ≤ 14 days prior to registration) * Total bilirubin ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration) * Serum creatinine ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration) * Provide written informed consent * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Willing to use a highly effective method of contraception from the first dose of study medication through 180 days after the last dose of study medication, for persons of childbearing potential or persons able to father a child only * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)	* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown: * Pregnant persons. * Nursing persons. * Persons of childbearing potential who are unwilling to employ adequate contraception * Systemic anti-neoplastic therapy or radiation therapy ≤ 14 days prior to registration * Major surgical procedure ≤ 28 days prior to registration * Ongoing therapy related events \> grade 2 * Presence of another primary malignancy not in remission * New York Heart Classification 3 or greater heart failure * QT/corrected QT (QTc) interval \> 470 ms using Fredericia's QT correction formula * Uncontrolled brain metastatic disease * Uncontrolled infection * Any other comorbidities within the opinion of the investigator interfere with the investigation of the protocol * Usage of drugs that strongly inhibit or induce CYP3A4 ≤ 7 days prior to registration and for the duration of NXP800 dosing. Drugs that are low, medium, or other inhibitors of CYP3A4 are not prohibited and should be used with caution. Drugs that inhibit BCRP are not prohibited but should be used with caution, since NXP800 was found to be a BCRP substrate * Usage of seville oranges, grapefruit or grapefruit juice or products ≤ 7 days prior to registration and for the duration of NXP800 dosing * Unwillingness to follow study related procedures * Inability to provide informed consent

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years
* Histologically/cytologically confirmed biliary tract cancer
* Advanced or metastatic disease that is refractory to gemcitabine or fluoropyrimidine based therapy, or if there is intolerance to these regimens
* Measurable disease by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Anticipated life expectancy of \> 12 weeks
* Hemoglobin ≥ 9.0 g/dL (obtained ≤ 14 days prior to registration)
* Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 14 days prior to registration)
* Platelet count ≥ 100,000/mm\^3 (obtained ≤ 14 days prior to registration)
* Aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)
* Alanine aminotransferase (ALT) ≤ 5 x ULN (obtained ≤ 14 days prior to registration)
* Total bilirubin ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration)
* Serum creatinine ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration)
* Provide written informed consent
* Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Willing to use a highly effective method of contraception from the first dose of study medication through 180 days after the last dose of study medication, for persons of childbearing potential or persons able to father a child only
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
* Pregnant persons.
* Nursing persons.
* Persons of childbearing potential who are unwilling to employ adequate contraception
* Systemic anti-neoplastic therapy or radiation therapy ≤ 14 days prior to registration
* Major surgical procedure ≤ 28 days prior to registration
* Ongoing therapy related events \> grade 2
* Presence of another primary malignancy not in remission
* New York Heart Classification 3 or greater heart failure
* QT/corrected QT (QTc) interval \> 470 ms using Fredericia's QT correction formula
* Uncontrolled brain metastatic disease
* Uncontrolled infection
* Any other comorbidities within the opinion of the investigator interfere with the investigation of the protocol
* Usage of drugs that strongly inhibit or induce CYP3A4 ≤ 7 days prior to registration and for the duration of NXP800 dosing. Drugs that are low, medium, or other inhibitors of CYP3A4 are not prohibited and should be used with caution. Drugs that inhibit BCRP are not prohibited but should be used with caution, since NXP800 was found to be a BCRP substrate
* Usage of seville oranges, grapefruit or grapefruit juice or products ≤ 7 days prior to registration and for the duration of NXP800 dosing
* Unwillingness to follow study related procedures
* Inability to provide informed consent

Contacts and Locations

Principal Investigator

Mitesh J. Borad, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Mitesh J. Borad, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-31

Study Completion Date2025-09-09

Study Record Updates

Study Start Date2024-05-31

Study Completion Date2025-09-09

Terms related to this study

Additional Relevant MeSH Terms

Advanced Cholangiocarcinoma
Metastatic Cholangiocarcinoma
Refractory Cholangiocarcinoma
Stage III Hilar Cholangiocarcinoma AJCC v8
Stage III Intrahepatic Cholangiocarcinoma AJCC v8
Stage IV Hilar Cholangiocarcinoma AJCC v8
Stage IV Intrahepatic Cholangiocarcinoma AJCC v8