Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02909777|
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Neuroblastoma Brain Tumor Solid Tumor||Drug: CUDC-907||Phase 1|
This is a Phase I clinical trial. A Phase I clinical trial tests the safety of an investigational intervention and also tries to find the best dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved CUDC-907 as a treatment option for any disease.
This is the first time that CUDC-907 will be given to children.
In this research study, the investigators are evaluating a new drug, CUDC-907, as a potential new treatment for children with solid tumors, lymphomas and brain tumors. CUDC-907 is an oral drug that blocks certain proteins in tumor cells. These proteins may be important in the growth of some cancers. Laboratory experiments and results from adult studies demonstrate that CUDC-907 may stop tumor growth and, in some cases, cause tumor cells to die. CUDC-907 has been tested in adults with cancer to find out about side effects and dosing in adults. The primary goal of this study is to evaluate side effects of CUDC-907 and find the best dose of CUDC-907 when used in children. Other goals of this study are to determine whether this drug may have benefits against the types of cancer seen in children and to measure the effects of CUDC-907 in the blood.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2022|
- Dose Limiting Toxicity [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]
- Peak plasma concentration of CUDC-907 in Pediatrics [ Time Frame: 2 years ]Determined using standard methods and reported descriptively in aggregate and by assigned dose level.
- Exposure (AUC) of CUDC-907 in Pediatrics [ Time Frame: 2 years ]Determined using standard methods and reported descriptively in aggregate and by assigned dose level.
- Duration of Response [ Time Frame: 2 years ]
- Adverse Events per CTCAE Version 4 [ Time Frame: 2 years ]
- Objective Response [ Time Frame: 2 months ]
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): NCT02909777
|Contact: Steven DuBois, MD, MSfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco, Benioff Children's Hospital||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Kieuhoa Vo, MD 415-476-3831 email@example.com|
|Principal Investigator: Kieuhoa Vo, MD|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Steven DuBois, MD, MS 617-632-5460 firstname.lastname@example.org|
|Principal Investigator: Steven DuBois, MD, MS|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Elizabeth Fox, MD 267-425-3010 email@example.com|
|Principal Investigator: Elizabeth Fox, MD|
|United States, Texas|
|Texas Children's, Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jodi Muscal, MD 832-824-4632 firstname.lastname@example.org|
|Principal Investigator: Jodi Muscal, MD|
|Principal Investigator:||Steven DuBois, MD, MS||Dana-Farber Cancer Institute|