Clinical trialPhase 1 / Phase 2Terminated
Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer
A Phase 1b and Pharmacodynamic Study of Nintedanib Monotherapy for Advanced Pancreatic Cancer
- Outcome
- Stopped earlyThe study was terminated due to futility and lack of future funding (Efficacy or futility)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 7 September 2017
- Expected end
- 26 October 2021
- Enrollment
- 14 participants
- Sites
- 1
- Primary outcomes
- Maximum Tolerated Dose (MTD)
- Sponsor
- Other
- Results posted
- 2024-06-03
- Last update
- 3 June 2024
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
Preclinical data suggest nintedanib inhibits primary tumor growth in in vivo xenograft models of pancreatic cancer, as well as inhibiting metastasis in pancreatic cancer models. This effect appears primarily due to nintedanib anti-angiogenic properties. 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. For each patient, treatment will have two phases: nintedanib monotherapy for a two week period (Days 1-14) followed by combination phase of nintedanib plus chemotherapy (Cycle 2+).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) [Each 28 day cycle for up to 2 years]. Number, mg. All Participants (n=13): 200.