A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
- Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Registration Number
- JPRN-jRCT2031210394
- Lead Sponsor
- Hirano Takamitsu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 490
Applicable for both Safety run-in and Randomized part
- Participants aged >=18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery
- Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Adequate organ function (assessed by central laboratory for eligibility)
- Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade =< 1 (CTCAE v 5.0) at time of screening, except alopecia.
Applicable for both Safety run-in and Randomized part
- Previous systemic anti-cancer treatment for metastatic PDAC
- Pancreatic neuroendocrine, acinar, or islet tumors
- Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening).
- Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment.
- Radiation therapy or brain radiotherapy =< 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed =< 2 weeks prior to start of study treatment).
- Impaired cardiac function or clinically significant cardio-vascular disease
- Use of hematopoietic growth factors or transfusion support =< 2 weeks prior to start of study treatment.
- Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
- Serious non-healing wounds.
- Pregnant or breast-feeding women
- Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated
- Pre-existing peripheral neuropathy > grade 1 (CTCAE v5.0)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method