Olaparib + Sapacitabine in BRCA Mutant Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03641755|
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : July 8, 2019
This research study is studying a combination of drugs as a possible treatment for breast cancer with a BRCA mutation.
The interventions involved in this study are:
- Sapacitabine (CYC682)
- Olaparib (Lynparza™)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Sapacitabine Drug: Olaparib||Phase 1 Phase 2|
This is a Phase I/II clinical trial. A Phase I clinical trial 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. It also means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of Olaparib and Sapacitabine as a treatment for any disease.
The FDA (the U.S. Food and Drug Administration) has approved Olaparib as a treatment for metastatic HER2 negative breast cancer with a BRCA mutation. Olaparib is an inhibitor of PARP (poly [adenosine diphosphate-ribose] polymerase), which means that it stops PARP from working. PARP is an enzyme (a type of protein) found in the cells of the body. In normal cells when DNA is damaged, PARP helps to repair the damage.
The FDA has not approved Sapacitabine for use in patients including people with this type of cancer. Sapacitabine and drugs of its class have been shown to have antitumor properties in many types of cancer, e.g., leukemia, lung, breast, ovarian, pancreatic and bladder cancer. Sapacitabine may help to stop the growth of some types of cancers.
In this research study, the investigators are evaluating the safety and effectiveness of Olaparib in combination with Sapacitabine in BRCA mutant breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of Olaparib With Sapacitabine in BRCA Mutant Breast Cancer|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||June 22, 2020|
|Estimated Study Completion Date :||June 22, 2025|
Experimental: Olaparib + Sapacitabine
Sapacitabine may help to stop the growth of some types of cancers
Other Name: CYC682
Olaparib is an inhibitor of PARP (poly [adenosine diphosphate-ribose] polymerase), which means that it stops PARP from working
Other Name: Lynparza
- Maximum Tolerated Dose [ Time Frame: 28 days ]The number and type of DLTs as defined in the protocol that occur during the first 28 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE v5.0 will be used to identify a safe and tolerable dose
- Recommended Phase II dose (RPIID) [ Time Frame: 28 days ]The number and type of DLTs as defined in the protocol that occur during the first 28 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE v5.0 will be used to identify a safe and tolerable dose
- Objective Response Rate [ Time Frame: 2 years ]Assessed by RECIST 1.1
- Progression-Free Survival [ Time Frame: 5 years ]Assessed by RECIST 1.1
- Dose Limitity Toxicity [ Time Frame: 28 days ]Toxicities will be defined according to NCI CTCAE, Version 5.0
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): NCT03641755
|Contact: Sara M. Tolaney, MD MPH||617-632-2335||Sara_Tolaney@DFCI.HARVARD.EDU|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Sara M. Tolaney, MD MPH 617-632-2335 Sara_Tolaney@dfci.harvard.edu|
|Principal Investigator: Sara M. Tolaney, MD MPH|
|Broad Institute of MIT||Active, not recruiting|
|Cambridge, Massachusetts, United States, 02142|
|Principal Investigator:||Sara M. Tolaney, MD MPH||Dana-Farber Cancer Institute|