Phase 2 LCL-161 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF) or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)
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|ClinicalTrials.gov Identifier: NCT02098161|
Recruitment Status : Recruiting
First Posted : March 27, 2014
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: LCL-161 Behavioral: Questionnaires Other: Phone Calls||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Phase 2 Single Agent Study of LCL-161 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)|
|Actual Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Starting dose of LCL-161 1500 mg by mouth on Days 1, 8, 15, and 22 of each 28 day cycle. Participants remain on study treatment, in the absence of disease progression or toxicity warranting discontinuation of therapy, as long as there is evidence of clinical benefit, as judged by the treating physician.
Starting dose of LCL-161 1500 mg by mouth on Days 1, 8, 15, and 22 of each 28 day cycle.
Questionnaire completion at baseline, day 1 of cycle 2 and beyond, and at end of treatment visit. The questionnaires should take about 5-10 minutes to complete.
Other Name: Surveys
Other: Phone Calls
Study staff to call participant 1 time each month, and at 30 days after end of treatment visit.
- Objective Response (OR) of LCL-161 [ Time Frame: After 3, 28 day cycles ]Objective response (OR), defined as CR (complete remission) + PR (partial remission) + CI (clinical improvement) for myelofibrosis (MF) patients after 3 cycles of treatment. Categorized according to the International Working Group (IWG) consensus criteria for myelofibrosis .
- Time to Response [ Time Frame: Day 1 of third, 28 day cycle ]Time to response defined as time from study registration to the first date at which the subject's objective status was classified as a response (CR or PR). In subjects who do not achieve a response, time to response censored at the subject's last evaluation date. The distribution for each of these event-time variables (duration of response and time to response) estimated by Kaplan-Meier curves.
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): NCT02098161
|Contact: Naveen Pemmaraju, MD||713-792-4956|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naveen Pemmaraju, MD||M.D. Anderson Cancer Center|