A Phase II Trial Evaluating WNT974 in Patients With Metastatic Head and Neck Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02649530|
Recruitment Status : Withdrawn (funding withdrawn)
First Posted : January 7, 2016
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma, Head And Neck||Drug: WNT974||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Non-randomized Phase II Trial Evaluating WNT974 in Patients With Metastatic Head and Neck Squamous Cell Carcinoma|
|Estimated Primary Completion Date :||July 2018|
Patients will receive 10 mg of WNT974 daily by mouth.
- The number of patients with stable disease, complete response and partial response [ Time Frame: 4 months ]Disease control rate will be assessed by examining the number of patients with stable disease, complete and partial response.
- Number of patients that respond to treatment [ Time Frame: 4 months ]The overall response rate will be determined. Overall response will be defined as the sum of complete response + partial response.
- Duration of time from start of treatment to time of progression [ Time Frame: 6 months post treatment ]Progression free survival in patients with metastatic head and neck cancer will be determined.
- The number of patients alive at 6 months post treatment [ Time Frame: 6 months post treatment ]Overall survival will be examined.
- The number of patients that experience adverse events [ Time Frame: 4 weeks post treatment ]Toxicities associated with the treatment of WNT974 will be assessed.
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): NCT02649530
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Francis Worden, M.D.||University of Michigan Rogel Cancer Center|