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)

JRCT ID: jRCT2031210394

Registered date:28/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Pancreatic Ductal Adenocarcinoma
• Date of first enrollment: 24/11/2021
• Target sample size: 490
• Countries of recruitment: Commonwealth of Australia,Japan,Republic of Korea,Japan,Republic of Singapore,Japan,Republic of China,Japan,Republic of Turkey,Japan,Kingdom of Belgium,Japan,Czech Republic,Japan,Republic of Finland,Japan,French Republic,Japan,Federal Republic of Germany,Japan,Hellenic Republic,Japan,Republic of Hungary,Japan,State of Israel,Japan,Republic of Italy,Japan,Kingdom of the Netherlands,Japan,Kingdom of Norway,Japan,Russian Federation,Japan,Slovak Republic,Japan,Kingdom of Spain,Japan,Kingdom of Sweden,Japan,Swiss Confederation,Japan,United Kingdom of Great Britain and Northern Irela,Japan,Argentine Republic,Japan,Federative Republic of Brazil,Japan,Canada,Japan,People's Republic of China,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

The treatment period begins on Cycle 1 Day 1. The duration of each treatment cycle is 28 days.
The study drugs will be administered at the recommended dose and/or per label as follows:
Safety run-in part:
- NIS793 at 2100 mg (Days 1 and 15)
- Gemcitabine at 1000 mg/m2 (Days 1, 8 and 15)
- Nab-paclitaxel at 125 mg/m2 (Days 1, 8 and 15)

Randomized part:
- NIS793 at 2100 mg or placebo (Days 1 and 15) assuming this is the confirmed the recommended dose in the safety run-in part.
- Gemcitabine at 1000 mg/m2 (Days 1, 8 and 15)
- Nab-paclitaxel at 125 mg/m2 (Days 1, 8 and 15)

Outcome(s)

Primary Outcome

- Safety run-in part:
Incidence of DLTs during the first cycle (4 weeks) of treatment

- Randomized part:
Overall Survival (OS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

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)

Related Information

• Primary Sponsor: Hirano Takamitsu
• Secondary ID(s): NCT04935359