Pancreatic ductal adenocarcinoma MedDRA version: 21.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 100000004864
Conditions
Interventions
Product Code: NIS793
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not yet defined
Current Sponsor code: NIS793
Other descriptive name: NIS793
Concentration unit: mg/
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 290
Exclusion criteria
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, (inslet) acinar or 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 = 2), or clinically significant arrhythmia - acute myocardial infarction, unstable angina pectoris, coronary stenting or bypass surgery 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 (patients with a history of HCV infection must have been treated with confirmation of cure to be eligible) 12. active untreated or uncontrolled systemic fungal, bacterial or viral infections 13. use of hematopoietic growth factors or transfusion support 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: safety run in: to confirm the recommended phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and nab-paclitaxel randomized part: to compare OS in participants with mPDAC treated as the first line treatment with the combination of NIS793, gemcitabine and nab-paclitaxel to the combination of placebo with gemcitabine and nab-paclitaxel;Secondary Objective: safety run in: 1. safety and tolerability of NIS793 in combination with SoC 2. PK of NIS793 in combination with SoC 3. preliminary anti-tumor activity of NIS793 in combination with SoC randomized part: 1. efficacy (PFS, ORR, DCR; DOR, TTR) of NIS793 in combination with SoC versus placebo in combination with SoC 2. safety and tolerability in each treatment arm 3. explore PK of NIS793 in combination with gemcitabine and nabpaclitaxel 4. characterize the incidence of immunogenicity of NIS793 in combination with gemcitabine/nab-paclitaxel;Primary end point(s): safety run in: incidence of DLTs in the first cycle randomized part: OS;Timepoint(s) of evaluation of this end point: safety run in: 4 weeks of treatment randomized part: at participants' death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): safety run in: 1. safety: incidence and severity of AEs 2. tolerability: dose interruptions, dose reductions, dose intensity 3. PK parameters for NIS793 in combination with SoC 4. PFS, ORR, DCR, DOR, TTR randomized part: 1. PFS, ORR, DCR, DOR, TTR 2. incidence and severity of AEs and SAEs, dose interruptions, dose reductions 3. For participants with intense PK sampling enrolled in China, NIS793 serum concentrations over time and derived PK parameters (e.g. Cmax, AUC) 4. For participants without intensive PK sampling, PK parameters including Cmax, Ctrough and Ctroughss for NIS793 5. Anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment;Timepoint(s) of evaluation of this end point: safety run in: 1-3. first 4 weeks of treatment 4. end of study randomized part at protocol defined timepoints (12 weeks) end of study | — |
Countries
Australia, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactMedical Information Service
Novartis Finland Oy
Outcome results
None listed