Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype
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|ClinicalTrials.gov Identifier: NCT01534260|
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: sorafenib, vorinostat and bortezomib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype|
|Actual Study Start Date :||February 10, 2012|
|Actual Primary Completion Date :||August 29, 2016|
|Actual Study Completion Date :||February 13, 2017|
Experimental: sorafenib, vorinostat and bortezomib
Escalating cohorts of sorafenib, vorinostat and bortezomib
Drug: sorafenib, vorinostat and bortezomib
Escalating dose cohorts of sorafenib, vorinostat and bortezomib. The first cohort will receive sorafenib from day 1 to 14, vorinostat will be given on days 1-4 and 8-12, and bortezomib will be given on days 1 and 8. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
- Number of Patients With Dose Limiting Toxicity [ Time Frame: up to 9 months ]The number of patients who had a DLT during the dose finding/confirming portion (Phase I) of the trial for the safety of the combination of sorafenib, vorinostat, and bortezomib.
- Phase II - Percentage of Patients With a Partial Response or Greater [ Time Frame: up to 9 months ]Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the response criteria determined by the International Working Group for AML.
- Phase II - Time to Relapse [ Time Frame: Up to one year ]Will be examined using Kaplan-Meier estimates. Time from date of confirmed complete remission to date of relapse. The observations of patients who died or remained alive and relapse free were censored at date of death or last disease evaluation, respectively.
- Phase II - Treatment-Related Adverse Events Grade 3 or Higher [ Time Frame: Up to one year ]Number of unique patients who had a treatment-related (possible, probable or definite) adverse events that were graded 3 or higher.
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): NCT01534260
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Hamid Sayar, MD||Indiana University Melvin and Bren Simon Cancer Center|