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Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

NCT04935359

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Interventions: NIS793, Nab-paclitaxel, Gemcitabine, Placebo

Countries: United States, Australia, Belgium, Brazil, Canada, China, Czechia, Finland

The purpose of this study was to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aimed to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel could reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

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.

Key Main Exclusion Criteria:

Applicable for both Safety run-in and Randomized part

* Previous systemic anti-cancer treatment for metastatic PDAC
* Pancreatic neuroendocrine (islet) or acinar 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)

Other Inclusion/Exclusion criteria may apply.
Locations (113)
  • Fayetteville, Arkansas, United States
  • Los Angeles, California, United States
  • Orlando, Florida, United States
  • Fort Wayne, Indiana, United States
  • New York, New York, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Seattle, Washington, United States
  • Adelaide, South Australia, Australia
  • Perth, Western Australia, Australia
  • Bonheiden, Belgium
  • Brussels, Belgium
  • Edegem, Belgium
  • Leuven, Belgium
  • Brasília, Federal District, Brazil
  • Ijuí, Rio Grande do Sul, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, São Paulo, Brazil
  • Brampton, Ontario, Canada
  • Cambridge, Ontario, Canada
  • Toronto, Ontario, Canada
  • Guangzhou, Guangdong, China
  • Harbin, Heilongjiang, China
  • Nanjing, Jiangsu, China
  • Dalian, Liaoning, China
  • Jining, Shandong, China
  • Xian, Shanxi, China
  • Chengdu, Sichuan, China
  • Hangzhou, Zhejiang, China
  • + 83 more on CT.gov