Clinical trialPhase 2Terminated
A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer
A Phase 2 Study of Neoadjuvant NIS793 in Combination With mFOLFIRINOX in Resectable and Borderline Resectable Pancreatic Adenocarcinoma (PDAC)
- Outcome
- Stopped earlyNovartis, the drug manufacturer of NIS793, notified Dana Farber Cancer Institute that they are stopping all clinical development of NIS793 in pancreatic cancer, effective immediately. (Other)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 6 January 2023
- Expected end
- 13 October 2023
- Enrollment
- 8 participants
- Sites
- 2
- Primary outcomes
- Major Pathological Response Rate (MPR)
- Sponsor
- Other
- Results posted
- 2024-07-16
- Last update
- 17 December 2024
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Brief summary public domain (ClinicalTrials.gov)
This study is being done to evaluate the safety and efficacy of adding NIS793 to standard of care FOLFIRINOX treatment for pancreatic cancer. The names of the study interventions involved in this study are: * NIS793 * FOLFIRINOX (Folinic acid/Leucovorin, 5-Fluorouracil, Irinotecan, and Oxaliplatin) Other interventions may include: * Chemoradiation Therapy * Surgery
Detailed description public domain (ClinicalTrials.gov)
This is a randomized phase 2 study evaluating the efficacy of NIS793, a TGF-beta inhibitor, when added to a standard chemotherapy program of modified FOLFIRINOX for people with previously-untreated, resectable or borderline resectable pancreatic adenocarcinoma. The U.S. Food and Drug Administration (FDA) has not approved NIS793 as a treatment for any disease. NIS793 works by blocking a molecule called TGF-beta. TGFbeta has been shown to promote the growth of pancreatic cancer and this study is examining if the addition of a TGF-beta blocking drug will allow the chemotherapy to work better against the cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be randomized into two groups of: * Arm A will receive standard chemotherapy, mFOLFIRINOX, in combination with NIS793. * Arm B will receive standard chemotherapy, mFOLFIRINOX. Based on study team determination, some participants may be offered chemoradiation following completion of chemotherapy and/or surgery following either completion of chemotherapy or chemoradiation. Study treatment is expected to last up to 16 weeks unless disease symptom worsens . It is expected that about 45 people will take part in this research study.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Major Pathological Response Rate (MPR) [Pathology review is done in surgery assessments, once within 14 days prior to the operation.]. Count Of Participants, Participants. mFOLFIRINOX + NIS793 (n=6): 0; mFOLFIRINOX (n=2): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Treatment-Related Toxicity Rate [Cycle 1 Day 1 through 30 days post last treatment date, up to 9 months.]. Count Of Participants, Participants. mFOLFIRINOX + NIS793 (n=6): 5; mFOLFIRINOX (n=2): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Median Progression-free Survival (PFS) [From randomization (or registration) to the earlier of progression or death due to any cause, up to 9 months. Participants alive without disease progression are censored at date of last disease evaluation.]. Median, days (Full Range). mFOLFIRINOX + NIS793 (n=4): 114 (108 to 118); mFOLFIRINOX (n=1): 122 (122 to 122).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Median Overall Survival (OS) [Post treatment follow up done at least once every 12 weeks (+/- 28 days), up to 9 months.]. Median, days (Full Range). mFOLFIRINOX + NIS793 (n=6): 184 (43 to 254); mFOLFIRINOX (n=2): 155.5 (85 to 226).