Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02902484|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : August 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Pancreas||Drug: Nintedanib||Phase 1 Phase 2|
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+).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b and Pharmacodynamic Study of Nintedanib Monotherapy for Advanced Pancreatic Cancer|
|Actual Study Start Date :||September 7, 2017|
|Estimated Primary Completion Date :||December 15, 2023|
|Estimated Study Completion Date :||June 2024|
Experimental: Nintedanib Monotherapy
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.
Nintedanib Monotherapy Followed by Combination Therapy of Nintedanib and Gemcitabine Plus nab-Paclitaxel
Other Name: Ofev, Vargatef
- Maximum Tolerated Dose (MTD) [ Time Frame: Each 28 day cycle for 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 phase of nintedanib plus chemotherapy. Two dose levels of nintedanib will be explored 150 mg IBD and 200 mg BID. The combination phase will include gemcitabine + nab-paclitaxel, and nintedanib. Patient treatment will consist of gemcitabine 1000 mg/m & nab-paclitaxel 120 mg/m. Treatment will be administered intravenously on days 1, 8, 15 every 28 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902484
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75063|
|Principal Investigator:||Salwan Al Mutar, MD||UT Southwestern|