Trametinib in Patients With Advanced Neurofibromatosis Type 1 (NF1)-Mutant Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03232892|
Recruitment Status : Terminated (Low Accrual)
First Posted : July 28, 2017
Results First Posted : December 3, 2019
Last Update Posted : December 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Trametinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase 2, single-arm, open label, multicenter clinical trial.|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Official Title:||Phase II Trial to Evaluate Trametinib in Patients With Advanced NF1-mutant Non-small Cell Lung Cancer|
|Actual Study Start Date :||February 13, 2018|
|Actual Primary Completion Date :||September 11, 2019|
|Actual Study Completion Date :||September 11, 2019|
Experimental: Trametinib 2.0mg PO daily
Trametinib 2.0mg PO daily in 28-day cycles. A maximum of two trametinib dose level reductions are allowed (1.5mg and 1mg) in the case of adverse reactions.
Trametinib 2mg, once daily, PO, 28-day cycles
Other Name: Mekinist
- Objective Response Rate (ORR) [ Time Frame: Up to 1 year ]For participants receiving at least one dose of study treatment, the ORR is defined as the best overall response recorded from the start of the treatment until disease progression or recurrence as assessed over a 1-year period from the start of treatment. The frequency and percentages of patients with a best overall response rate of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be determined. We will test the hypothesis that the ORR is greater than the null hypothesis of 10% using the Fisher's exact test.
- Duration of Response (DR) [ Time Frame: Up to 4 years ]The DR for Complete Response (CR) and Partial Response (PR) will be measured from the date that the best response is first recorded until the date that PD is documented. For patients who continue treatment post progression, the date of Disease Progression (PD) documentation will be used for analysis. The DR will be summarized using descriptive statistics (N, mean, standard deviation, minimum, and maximum).
- Disease Control Rate (DCR) According to RECIST Version 1.1 Criteria. [ Time Frame: Up to 4 years ]DCR will be defined as the percentage of patients who have achieved CR, PR, or SD for at least 12 weeks. The DCR will be summarized using descriptive statistics (N, mean, standard deviation, minimum, and maximum).
- Progression Free Survival (PFS) According to RECIST Version 1.1 Criteria. [ Time Frame: Up to 1 year ]PFS will be calculated as 1+ the number of days from the first dose of study drugs to documented radiographic progression or death due to any cause over a period of 1 year. For patients who continue treatment post-progression, the date of radiographic progression will be used for PFS analysis. For patients who continue treatment post-progression, the date of radiographic progression will be used for PFS analysis. The Kaplan-Meier analysis will be used to calculate the median PFS with 95% confidence interval.
- Overall Survival (OS) [ Time Frame: Up to 1 year ]OS will be calculated as 1+ the number of days from the first dose of study drugs to death due to any cause over a period of 1 year. The Kaplan-Meier analysis will be used to calculate the median OS with 95% confidence interval.
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): NCT03232892
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Study Chair:||Collin Blakely, MD, PhD||University of California, San Francisco|