ERK 1/2 Signaling in Ibrutinib Resistant B-cell Malignancies
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04043845|
Recruitment Status : Withdrawn (Business development reasons.)
First Posted : August 2, 2019
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Waldenstrom Macroglobulinemia Mantle Cell Lymphoma Marginal Zone Lymphoma||Drug: Ibrutinib Drug: LY3214996||Phase 1|
This research study is a Phase I clinical trial, which tests the safety of an investigational combination of drugs and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved LY3214996 as a treatment for any disease.
The U.S. Food and Drug Administration (FDA) has approved ibrutinib as a treatment option for this disease.
LY3214996 is an extracellular signal-regulated kinase (ERK) inhibitor that is being developed as a treatment for patients with advanced cancer. ERK inhibitors stop the signal that a cancer cell receives telling it to grow. In this research study, the investigators are testing to see if LY3214996 is safe when combined with ibrutinib in patients with specific gene mutations. Making treatment decisions based on genetic testing is investigational, and the FDA has not approved this genetic testing. Several doses of LY3214996 will be explored in this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study Targeting ERK 1/2 Signaling in Ibrutinib Resistant B-cell Malignancies|
|Actual Study Start Date :||February 3, 2020|
|Actual Primary Completion Date :||February 3, 2020|
|Actual Study Completion Date :||February 3, 2020|
Ibrutinib inhibits the function of Bruton's tyrosine kinase (BTK). Ibrutinib blocks signals that stimulate malignant B cells to grow and divide uncontrollably.
Other Name: Imbruvica
LY3214996 is an extracellular signal-regulated kinase (ERK) inhibitor. ERK inhibitors stop the signal that a cancer cell receives telling it to grow.
- Dose Limiting Toxicity [ Time Frame: 42 days ]Toxicities occurring following administration of protocol therapy, measured using CTCAE 5.0 criteria.
- Best Response [ Time Frame: From date of study drug initiation up to a maximum of 2 years ]Best response to study treatment measured using disease-specific criteria.
- Time to Progression [ Time Frame: From date of study drug initiation until the date of first documented progression or date of death from any cause, whichever comes first, up to a maximum of 2 years ]Assess the amount of time to disease progression
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): NCT04043845
|Principal Investigator:||Steven Treon, MD, PhD||Dana-Farber Cancer Institute|