18 and older, any sex, with Cancer of Pancreas. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD)Primary· Each 28 day cycle for up to 2 years
A standard 3+3 phase 1 trial design will be used for Nintedanib monotherapy for a two week period (Days 1-14) followed by combination therapy of nintedanib plus chemotherapy. Two dose levels of nintedanib will be explored 150 mg BID and 200 mg BID. The combination phase will include gemcitabine + nab-paclitaxel, and nintedanib. Treatment will be administered intravenously on days 1, 8, 15 every 28 days.
One cycle of Nintedanib monotherapy followed by a total of eight cycles of both Nintedanib and the chemotherapeutic agents, or until disease progression, whichever comes first.
1. Nintedanib
Group
Value
95% CI
All Participants
200
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected for 3 years, 1 month..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study will perform a clinical study evaluating the safety and tolerability of nintedanib when combined with standard chemotherapy (Gemcitabine + nab-Paclitaxel) for metastatic pancreatic cancer. It will utilize advanced imaging correlates including dynamic contrast enhanced Magnetic Resonance Imaging (DCE-MRI) which correlates with tumor grade and microvessel density.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu
· Phase 3
· recruiting
NCT07162961 — Nintedanib for Improving Reproductive Outcomes in Adenomyosis
· Phase 3
· not yet recruiting
NCT06297096 — Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease
· Phase 3
· recruiting
NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in
· Phase 1
· completed
NCT06643091 — Nintedanib Treatment in Unicentric Castleman Disease
· Phase 2
· not yet recruiting
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Currently open trials in the same condition.
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· recruiting
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· active not recruiting
NCT04677244 — Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level
· NA
· recruiting
Other University of Texas Southwestern Medical Center trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 3 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02902484.