A Study of Abemaciclib in Recurrent Glioblastoma
|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: NCT02981940|
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : August 2, 2021
This research study is studying a targeted therapy as a possible treatment for recurrent glioblastoma (GBM).
The following intervention will be used in this study:
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Abemaciclib Procedure: Surgery||Phase 2|
This research study is a Phase 0/II clinical trial. Phase 0 clinical trials use only a few small doses of a drug. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved abemaciclib as a treatment for any disease.
Many brain cancers show over expression of a protein called cyclin D1. That means that the body makes too much cyclin D1, which affects enzymes called CDK 4 and CDK 6. Enzymes are substances in the body that help reactions between cells happen. Too much cyclin D1 triggers CDK 4 and CDK 6 to make more cells than normal. This extra cell production leads to the growth of tumors.
In laboratory studies, Abemaciclib was able to enter the brain, stop CDK 4 and CDK 6 from making cells, and slow growth of mice Glioblastoma.
In this research study, the investigators are looking to see how safe and effect Abemaciclib is with the participant type of cancer. In the surgical participants, the investigators are looking to see if Abemaciclib reached the brain tumor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 0/2 Study of Abemaciclib in Recurrent Glioblastoma|
|Actual Study Start Date :||February 9, 2017|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2024|
Experimental: Abemaciclib with Surgery
Other Name: LY2835219
Experimental: Abemaciclib without Surgery
Other Name: LY2835219
Experimental: Cohort 1 Surgery Arm
Participants who require reoperation will be treated with abemaciclib for 10-14 days prior to surgery. Tissue will be used to further investigate the abilities of Abemaciclib. After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.
Other Name: LY2835219
- Intratumoral abemaciclib concentration [ Time Frame: 2 years ]
- 6-Month Progression Free Survival (PFS6) [ Time Frame: 6 months ]
- pRB expression level of tumor tissue [ Time Frame: 2 years ]
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 years ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: 4 months ]PK measurements expressed as Area under the plasma concentration versus time curve (AUC) of Abemaciclib [Time Frame C1D1 (pre-treatment), C2D1, C3D1 and C4D1 (each cycle is 28 days)].
- Peak Plasma Concentration (Cmax) [ Time Frame: 4 months ]PK measurements expressed as Peak Plasma Concentration (Cmax) of Abemaciclib [Time Frame C1D1 (pre-treatment), C2D1, C3D1 and C4D1 (each cycle is 28 days)]
- Radiographic Response Rate [ Time Frame: 2 years ]
- Median Progression Free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]
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): NCT02981940
|Contact: Eudocia Q Lee, MD MPHemail@example.com|
|Contact: Amanda Spearmanfirstname.lastname@example.org|
|United States, California|
|University of California Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Timothy Cloughesy, MD 310-825-5321 email@example.com|
|University of California, San Francisco||Active, not recruiting|
|San Francisco, California, United States, 94143-0372|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Isabel Arrillaga-Romany, MD, PhD 617-724-8770 firstname.lastname@example.org|
|Principal Investigator: Isabel Arrillaga-Romany, MD, PhD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Eudocia Q Lee, MD MPH 877-338-7425 email@example.com|
|Contact: Lisa Doherty, NP 877-338-7425 firstname.lastname@example.org|
|Principal Investigator: Eudocia Q Lee, MD MPH|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Active, not recruiting|
|New York, New York, United States, 10021|
|United States, Texas|
|UT, M.D. Anderson Cancer Center||Active, not recruiting|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Howard Colman, MD 801-587-4042 email@example.com|
|Principal Investigator:||Eudocia Q Lee, MD MPH||Dana-Farber Cancer Institute|