Combination Study of Prexasertib and Olaparib in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03057145|
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : February 4, 2019
This research study is studying a combination of targeted therapies as a possible treatment for Advanced Solid Tumors.
The study interventions involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Prexasertib Drug: Olaparib||Phase 1|
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate 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 LY2606368 as a treatment for any disease.
The FDA (the U.S. Food and Drug Administration) has approved Olaparib for ovarian cancer but it has not been approved for other uses.
LY2606368 is a checkpoint kinase 1 (CHK1) inhibitor that is being developed as a treatment for patients with advanced cancer. CHK1 inhibitors work by preventing the cancer cells from being able to repair damaged DNA (one of the building blocks of a cell) which then leads to cell death.
Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. PARP is a protein in the body that repairs damage to DNA. In cells that are rapidly growing such as cancer cells, blocking repair of DNA may be of benefit, since it will cause the cell to die.
In this research study, the investigators are combining LY2606368 with Olaparib in the hopes that it will be a safe combination and that the LY2606368 will enhance how the cancer will respond to Olaparib. In previous laboratory studies performed by treating cancer cells with a CHK1 inhibitor and a PARP inhibitor, it was found that the CHK1 inhibitor was successful in increasing efficacy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Combination Study of Prexasertib (LY2606368), CHK1 Inhibitor, and Olaparib, PARP Inhibitor, in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||March 10, 2017|
|Estimated Primary Completion Date :||February 25, 2020|
|Estimated Study Completion Date :||February 25, 2023|
Experimental: Prexasertib Combine with Olaparib
LY2606368 is a checkpoint kinase 1 (CHK1) inhibitor that is being developed as a treatment for patients with advanced cancer
Other Name: LY2606368
Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor.
Other Name: Lynparza
- Maximum Tolerated Dose [ Time Frame: 2 months ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Dose Limiting Toxicity as assessed by CTCAEv4.0 [ Time Frame: 1 month ]
- Pharmacokinetic Sampling - Peak Plasma Concentration (Cmax) [ Time Frame: 2 months ]
- Pharmacokinetic Sampling - Area Under the Plasma Concentration versus Time Curve (AUC) [ Time Frame: 2 months ]
- Anti-Tumor Effects Of The Combination Of Prexasertib And Olaparib by RECIST 1.1 [ Time Frame: 2 months ]
- Phospho-CDK Expression In Tumor Biopsies As A Marker Of Prexasertib Effect And Downstream Marker Of Target Engagement [ Time Frame: 1 month ]
- RAD51 Focus Formation and γ-H2AX Expression in tumor biopsies Post-Olaparib And Post-Combination Treatment as a marker of DNA damage [ Time Frame: 1 month ]
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): NCT03057145
|Contact: Khanh Do, MD||617-632-6992||Khanh_Do@DFCI.HARVARD.EDU|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Khanh Do, MD 617-632-6992|
|Principal Investigator: Khanh Do, MD|
|Principal Investigator:||Khanh Do, MD||Dana-Farber Cancer Institute|