RECRUITING

A Study to Evaluate the Safety and Tolerability of SX-682 in Combination with Nivolumab As a Maintenance Therapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

Conditions

Pancreatic Ductal Adenocarcinoma Pancreatic Cancer

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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

The main purpose of this research study is to determine the maximum tolerable dose (MTD) of SX-682 in combination with nivolumab in patients with metastatic pancreatic ductal adenocarcinoma who have completed at least 16 weeks of first line chemotherapy treatment without evidence of disease progression.

Official Title

An Open-label Phase 1 Study to Evaluate the Safety and Tolerability of SX-682 in Combination with Nivolumab As a Maintenance Therapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

Quick Facts

Study Start:2020-11-23

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04477343

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
1. Subjects must have the nature of the study explained to them 2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, pharmacokinetic collections, study biopsies and other requirements of the study. 3. Subjects (or an acceptable proxy) must provide a signed and dated IRB/IEC approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines for both the study and exploratory biomarker analysis obtained via paired biopsies. 4. Subjects (or an acceptable proxy) must provide a signed and dated Health Insurance Portability and Accountability Act (HIPAA) authorization. 5. The ICF and HIPAA authorization must be obtained before conduction and procedures that do not form a part of the subject's normal care. 6. After signing the ICF and HIPAA Authorization, subjects will be evaluated for study eligibility during the Screening Period (no more than 28 days before study drug administration) according to the following further inclusion/	1. Male or female subjects, aged at least 18 years 2. Have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma 3. Completion of at least 16 weeks of first line chemotherapy without evidence of disease progression 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 5. Must have measurable disease with at least 1 unidimensional measurable lesion per iRECIST 6. Screening laboratory values within 14 days prior to first dose of study drug: * 5 x ULN for subjects with liver metastases Bilirubin ≤ 1.5 mg/dL sa≤ 3.0 mg/dL for subjects with Gilbert's disease INR or PT ≤ 1.5 x ULN unless receiving anticoagulation therapy aPTT or PTT ≤ 1.5 x ULN unless receiving anticoagulation therapy 7. Life expectancy of ≥ 12 weeks as judged by the treating physician. 8. Patient must consent for baseline and on treatment biopsies 9. Patients must have baseline pulse oximetry ≥ 90% on room air

Inclusion Criteria

Exclusion Criteria

1. Subjects must have the nature of the study explained to them
2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, pharmacokinetic collections, study biopsies and other requirements of the study.
3. Subjects (or an acceptable proxy) must provide a signed and dated IRB/IEC approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines for both the study and exploratory biomarker analysis obtained via paired biopsies.
4. Subjects (or an acceptable proxy) must provide a signed and dated Health Insurance Portability and Accountability Act (HIPAA) authorization.
5. The ICF and HIPAA authorization must be obtained before conduction and procedures that do not form a part of the subject's normal care.
6. After signing the ICF and HIPAA Authorization, subjects will be evaluated for study eligibility during the Screening Period (no more than 28 days before study drug administration) according to the following further inclusion/

1. Male or female subjects, aged at least 18 years
2. Have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
3. Completion of at least 16 weeks of first line chemotherapy without evidence of disease progression
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
5. Must have measurable disease with at least 1 unidimensional measurable lesion per iRECIST
6. Screening laboratory values within 14 days prior to first dose of study drug:
* 5 x ULN for subjects with liver metastases Bilirubin ≤ 1.5 mg/dL sa≤ 3.0 mg/dL for subjects with Gilbert's disease INR or PT ≤ 1.5 x ULN unless receiving anticoagulation therapy aPTT or PTT ≤ 1.5 x ULN unless receiving anticoagulation therapy
7. Life expectancy of ≥ 12 weeks as judged by the treating physician.
8. Patient must consent for baseline and on treatment biopsies
9. Patients must have baseline pulse oximetry ≥ 90% on room air

Contacts and Locations

Study Contact

Chris LeFeber

CONTACT

585-275-0407

Chris_LeFeber@URMC.Rochester.edu

Principal Investigator

Daniel Mulkerin, MD

PRINCIPAL_INVESTIGATOR

University of Rochester Wilmot Cancer Center

Study Locations (Sites)

University of Rochester

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

Daniel Mulkerin, MD, PRINCIPAL_INVESTIGATOR, University of Rochester Wilmot Cancer Center

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 Date2020-11-23

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-11-23

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer

Additional Relevant MeSH Terms

Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer