Clinical Trials Using Nintedanib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Nintedanib. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-5 of 5
  • Nintedanib and Azacitidine in Treating Participants with HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia

    The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. “Investigational” means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant’s response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant’s leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.
    Location: Northwestern University, Chicago, Illinois

  • Nivolumab, Ipilimumab, and Nintedanib in Treating Patients with Advanced or Metastatic Non-small Cell Lung Cancer

    This phase I / II trial studies the best dose of nintedanib when given together with nivolumab and ipilimumab and to see how well they work in treating patients with non-small cell lung cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nintedanib, nivolumab and ipilimumab may work better in treating patients with non-small cell lung cancer.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Nintedanib Alone followed by Nintedanib, Gemcitabine Hydrochloride, and Nab-paclitaxel in Treating Participants with Locally Advanced or Metastatic Pancreatic Adenocarcinoma

    This phase 1b / II trial studies the side effects of nintedanib alone followed by nintedanib, gemcitabine hydrochloride, and nab-paclitaxel in treating participants who have pancreatic adenocarcinoma that has spread to nearby tissue or lymph nodes, or has spread to other places in the body. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nintedanib in combination with gemcitabine hydrochloride and nab-paclitaxel may kill more tumor cells in participants with advanced pancreatic adenocarcinoma.
    Location: UT Southwestern / Simmons Cancer Center-Dallas, Dallas, Texas

  • Nintedanib, Idarubicin Hydrochloride, and Cytarabine in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia

    This phase I / II trial studies the side effects of nintedanib, idarubicin hydrochloride, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Nintedanib may stop the growth of tumor cells by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as idarubicin hydrochloride and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nintedanib, idarubicin hydrochloride, and cytarabine may work better in treating patients with acute myeloid leukemia.
    Location: 2 locations

  • Nintedanib and Prednisone in Reducing Radiation-Induced Pneumonitis in Patients with Lymphoma, Chest, or Breast Cancer or Lung Metastases

    This randomized phase II trial studies how well nintedanib and prednisone work in reducing radiation-induced inflammation of the lungs (pneumonitis) in patients with lymphoma, chest, or breast cancer or cancer that has spread to the lung (lung metastases). Nintedanib and prednisone may help to reduce the development of swelling and scarring in the lungs caused by previous radiation therapy.
    Location: 10 locations