Study of efficacy and safety of NIS793 in combination with standard of care (SOC) chemotherapy in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 490

Inclusion Criteria

Participants eligible must meet all of the following criteria:
1. signed ICF prior to study treatment
2. age >= 18 years at the time of ICF
3. histologically or cytologically confirmed mPDAC eligible for treatment in first line setting and not amenable for potentially curative surgery
4. presence of at least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1
5. ECOG performance status 0-1
6. adequate organ function as defined by the following laboratory values:
- ANC >= 1.5 x 10*9 /L
- platelets >= 100 x 10*9/L
- hemoglobin >= 9g /dL
- calculated creatinine clearance >= 60 mL/min
- albumin >= 3 g/dL
- PT/INR and PTT <= 1.5 x ULN
- total bilirubin <= 1.5 X ULN
- AST and/or ALT <= 3.0 x ULN
7. WCBP must have negative pregnancy test during screening and before starting study treatment
8. able to adhere to study visit schedule and other protocol requirements
9. must have recovered from treatment-related toxicities of prior anticancer therapies to grade <= 1 (CTCAE v 5.0), except alopecia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 290

Exclusion Criteria

participants meeting any of the following criteria are not eligible for
inclusion:
1. previous systemic anti-cancer treatment for mPDAC
2. pancreatic neuroendocrine, acinar or inslet tumors
3. known status of MSI-H or MMR-deficient pancreatic cancer
4. presence of symptomatic CNS metastases, or CNS metastases that requires direct therapy or increasing doses of corticosteroids 2 weeks prior to study entry
5. known history of severe allergy or hypersensitivity to any of the study drug or their excipients
6. currently receiving any of the prohibited medications which cannot be discontinued within >= 7 days or 5 half-lifes, whichever is longer
7. not recovered from a major surgery or has a major surgery within 4 weeks prior to start of the study
8. radiation therapy or brain radiotherapy <= 4 weeks prior to study start
9. impaired cardiac function or clinically significant cardio-vascular disease, such as:
- congestive heart failure requiring treatment (NYHA grade >= 2), or clinically significant arrhythmia
- acute myocardial infarction, unstable angina pectoris, coronary stenting or bypass surgery < 3 months prior to study entry
- LVEF < 50%
- elevated cardiac enzymes (troponin I) > 2 x ULN
- cardiac valvulopathy >= grade 2
- uncontrolled hypertension
10. history of positive test for HIV infection
11. active or chronic HBV or HCV infections
12. active untreated or uncontrolled systemic fungal, bacterial or viral infections
13. use of hematopoietic growth factors or transfusion support <= 2 weeks prior to start the study
14. conditions that are considered to have a high risk of clinically significant gastrointestinal track bleeding or any other condition associated with or history of significant bleeding
15. serious, non-healing wounds
16. pre-existing peripheral neuropathy > grade 1
17. concurrent malignancy other than disease under treatment
18. any significant medical condition, laboratory abnormality or psychiatric or social condition that would constitute unacceptable risk to the patients, contraindicate participation, limit patient's ability to comply with study requirements or compromise patient's compliance with the study protocol
19. pregnant or breast-feeding woman
20. WCBP, unless using highly effective method of contraception during and up to 90 days after the study drug treatment (NIS793)
21. currently receiving other anti-cancer therapy or received other investigational product within 30 days or 5 half-lives prior to study treatment, whichever is longer

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 3/4/2019

Study of efficacy and safety of NIS793 in combination with standard of care (SOC) chemotherapy in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)

Recruitment & Eligibility

Study & Design

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