A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)
- Conditions
- alvleesklier kankermetastatic pancreatic cancer
- Registration Number
- NL-OMON51502
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
- Age >= 18 years
- Histologically or cytologically confirmed mPDAC eligible for treatment in
first line setting and not amenable for potentially curative surgery
- Presence of at least one measurable lesion assessed by CT and/or MRI
according to RECIST 1.1
- ECOG performance status 0-1
- Adequate organ function
- WCBP must have negative pregnancy test during screening and before starting
study treatment
- Must have recovered from treatment-related toxicities of prior anticancer
therapies to grade <= 1 (CTCAE v 5.0), except alopecia
- previous systemic anti-cancer treatment for mPDAC
- pancreatic neuroendocrine, acinar or inslet tumors
- known status of MSI-H or MMR-deficient pancreatic cancer
- presence of symptomatic CNS metastases, or CNS metastases that
requires direct therapy or increasing doses of corticosteroids 2 weeks prior to
study entry
- known history of severe allergy or hypersensitivity to any of the study drug
or their excipients
- currently receiving any of the prohibited medications which cannot be
discontinued within >= 7 days or 5 half-lifes, whichever is longer
- not recovered from a major surgery or has a major surgery within 4 weeks
prior to start of the study
- radiation therapy or brain radiotherapy <= 4 weeks prior to study start
- impaired cardiac function or clinically significant cardio-vascular disease
- history of positive test for HIV infection
- 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)
- active untreated or uncontrolled systemic fungal, bacterial or viral
infections
- use of hematopoietic growth factors or transfusion support <= 2 weeks prior
to start the study
- 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
- serious, non-healing wounds
- pre-existing peripheral neuropathy > grade 1
- concurrent malignancy other than disease under treatment
- pregnant or breast-feeding woman
- WCBP, unless using highly effective method of contraception during and up to
90 days after the study drug treatment NIS793
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety run-in part:<br /><br>The primary objective of the safety run-in part is to confirm the recommended<br /><br>phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and<br /><br>nab-paclitaxel (SOC).<br /><br>Randomized part:<br /><br>The primary objective of the randomized part is to compare OS in participants<br /><br>with mPDAC treated as the first line treatment with the combination of NIS793,<br /><br>gemcitabine and nab-paclitaxel to the combination of placebo with gemcitabine<br /><br>and nab-paclitaxel.<br /><br>The primary clinical question of interest of the randomized part is to estimate<br /><br>the treatment effect on the primary endpoint of OS of NIS793 in combination<br /><br>with gemcitabine and nab-paclitaxel (arm A) compared to placebo in combination<br /><br>with gemcitabine and nab-paclitaxel (arm B) for the target population,<br /><br>regardless of discontinuation from study treatment, or start of a new<br /><br>subsequent antineoplastic therapy.</p><br>
- Secondary Outcome Measures
Name Time Method