A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer
|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: NCT03144804|
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : October 5, 2018
This research study is studying a drug as a possible treatment for p53 mutant metastatic colorectal cancer.
The drug involved in this study is:
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Drug: Lamivudine||Phase 2|
This research study is a Phase II clinical trial. 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 lamivudine for this specific disease but it has been approved for other uses.
In this research study, the investigators are studying the effects of lamivudine on this type of cancer. This drug may help prevent the growth and spread of the cancer cells to other parts of the body. The investigators have discovered that this particular type of colon cancer, which has a p53 mutation may be sensitive to treatment with lamivudine by impairing the ability of the cancer cells to grow.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer|
|Actual Study Start Date :||October 31, 2017|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2024|
This drug may help prevent the growth and spread of the cancer cells to other parts of the body.
Other Name: Combivir
- Overall Response Rate [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]
- Overall Disease Control Rate [ 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): NCT03144804
|Contact: Aparna R Parikh, MD||617-724-4000||Aparna.Parikh@mgh.harvard.edu|
|United States, Massachusetts|
|Massachusetts general Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Aparna R. Parikh, MD 617-724-4000 Aparna.Parikh@mgh.harvard.edu|
|Principal Investigator: Aparna R. Parikh, MD|
|Principal Investigator:||Aparna R. Parikh, MD||Massachusetts General Hospital|