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| Name | Class |
|---|---|
| Syntrix Biosystems, Inc. | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
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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.
In this study the investigator would like to better understand 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. In addition, the investigator would like to measure the SX-682 pharmacokinetic data in humans. The investigator would also like to assess the immunophenotypic and stromal changes to the tumor microenvironment after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: SX-682 and Nivolumab | Experimental | SX-682 Dose: 25, 50, 100, 200, 400mg BID taken as an oral pill Nivolumab Dose: 240mg, every 2 weeks via intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SX-682 | Drug | Allosteric inhibitor to human CXCR1 and CXCR2 receptor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerable dose [Safety and Tolerability] | Maximum tolerable dose is defined by less than or equal to 30% dose limiting toxicity (DLT) event rate within a given dose combination, | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Measure of time from study enrollment until progression. | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Overall Survival |
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Inclusion Criteria:
Written Informed Consent and HIPAA Authorization
Study Population/Inclusion Criteria
Male or female subjects, aged at least 18 years
Have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
Completion of at least 16 weeks of first line chemotherapy without evidence of disease progression
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Must have measurable disease with at least 1 unidimensional measurable lesion per iRECIST
Screening laboratory values within 14 days prior to first dose of study drug:
WBC ≥ 3000/µL Neutrophils ≥ 1500/µL Platelets ≥ 100,000>µL Hemoglobin ≥ 9.0 g/dL in the absence of blood transfusion Creatinine ≤ 1.5 mg/dL AST/ALT ≤ 2.5 x ULN for subjects with no liver metastases
Life expectancy of ≥ 12 weeks as judged by the treating physician.
Patient must consent for baseline and on treatment biopsies
Patients must have baseline pulse oximetry ≥ 90% on room air
Exclusion Criteria:
Target Disease Exceptions:
Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI- except where contraindicated, in which case a CT scan is acceptable) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study dry administration.
Medical History and Concurrent Disease
Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results. Specifically:
Physical and Laboratory Test Findings
Allergies and Adverse Drug Reaction
Sex and Reproductive Status/Special Populations
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Mulkerin, MD | University of Rochester Wilmot Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| Nivolumab Injectable Product |
| Drug |
humanized monoclonal antibody to program cell death receptor 1 (PD1) |
|
Measure of time from study enrollment until death from any cause. |
| From date of enrollment until date of death from any cause up to 24 months |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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