A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
|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: NCT01638676|
Recruitment Status : Recruiting
First Posted : July 12, 2012
Last Update Posted : November 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Vemurafenib Drug: Metformin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Vemurafenib and Metformin to Unresectable Stage IIIC and Stage IV BRAF.V600E+ Melanoma Patients|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
|Experimental: Vemurafenib and Metformin||
Vemurafenib (960 mg PO daily) in patients with unresectable BRAFV600E positive Stage IIIC and Stage IV melanoma
Other Name: Vemurafenib branded as Zelboraf
Metformin (500 mg PO BID x 2 weeks, then 850 mg PO BID)
Other Name: Metformin hydrochloride branded as Glucophage
- Observation of CTCAE grade 4 or higher adverse events in six patients [ Time Frame: Duration of phase I portion, approximately six months ]In the phase I portion, six patients will be enrolled and observed for CTCAE grade 4 or higher events. If three or more grade 4 or higher adverse events are observed among the six patients, the study will be halted.
- Overall Survival Follow up [ Time Frame: Every 12 weeks (+/- 7 days) after last drug dose, for up to 3 full years ]Patients will be followed for up to three years following the last treatment administration. The Investigator or designees will make every possible attempt at least every 12 weeks (±7 days), for up to three years after the last treatment to contact the patient or family to obtain the survival information of the patient and, if applicable, the start date of additional anticancer treatment.
- Number of adverse events [ Time Frame: Duration of study, estimated to be approximately 60 months ]Descriptive statistics of all AEs observed during the study period.
- type of adverse events [ Time Frame: Duration of study, estimated to be approximately 60 months ]Descriptive statistics of all AEs observed during the study period.
- Objective response rate (ORR)as measure of efficacy [ Time Frame: Duration of study (approximately 60 months) ]Efficacy estimated as the objective response rate (ORR), which is the sum of Partial Responses (PR) and Complete Responses (CR) as determined by RECIST 1.1
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): NCT01638676
|United States, Kentucky|
|James Graham Brown Cancer Center-University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Jason A Chesney, MD PhD 502-562-3429 email@example.com|
|Contact: Sarah Lush, RN 502-540-1537 firstname.lastname@example.org|
|Principal Investigator:||Jason A Chesney, MD PhD||James Graham Brown Cancer Center-U of Louisville|