Clinical Study of WT2725 in Patients With Advanced Malignancies
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01621542|
Recruitment Status : Completed
First Posted : June 18, 2012
Results First Posted : April 5, 2019
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: WT2725||Phase 1|
Treatment with other WT1 vaccines in clinical trials has shown evidence of immunogenicity and clinical response in various malignancies.
This study will assist with determining which dose level(s) to use in future clinical studies and will evaluate both clinical and immunological response.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||Initial Phase 1 Study of WT2725 in Patients With Advanced Malignancies|
|Actual Study Start Date :||July 31, 2012|
|Actual Primary Completion Date :||May 17, 2017|
|Actual Study Completion Date :||May 17, 2017|
WT2725 injection Study drug will be administered every 1-4 weeks
- Occurrence of Dose-limiting Toxicities and Adverse Events [ Time Frame: Up to 4 months ]Evaluation of the safety and tolerability of WT2725 Dosing Emulsion based on the occurrence of DLT and AEs The safety and tolerability of WT2725 Dosing Emulsion will be evaluated based on the occurrence of DLT and AEs, and the findings from clinical laboratory tests, vital signs measurements, body weight measurements, and electrocardiogram (ECG) results. The incidence of DLT will be evaluated during the DLT Evaluation Period, which extends from the day of the first dose to just prior to the fifth dose of study drug (Days 1 to 29). No more than 4 doses of study drug will be administered during the DLT Evaluation Period.
- Maximum Tolerated Dose (MTD) of WT2725 Based on the Evaluation of Dose-limiting Toxicity (DLT) [ Time Frame: Day 1 - Day 29 ]
- Antitumor Responses to WT2725 Based on the Immune-related Response Criteria (irRC) [ Time Frame: Day 1 - within 28 days after last dose ]Tumor response, as evaluated according to irRC, was based on total measurable tumor burden in patients with solid tumors (ie, non-AML patients). Tumor assessments will be conducted during screening, and then every 8 weeks after the first dose of study drug. All tumor assessments may be performed within ±7 days of the scheduled assessment. All patients should complete an End of Study visit within 28 days after the last dose of study drug and prior to the start of alternate antineoplastic therapy.
- Immune Response to WT2725 [ Time Frame: Day 1 - within 28 days after last dose ]The modified IWG response criteria were used to assess drug activity in AML patients. Tumor assessments will be conducted during screening, and then every 8 weeks after the first dose of study drug. All tumor assessments may be performed within ±7 days of the scheduled assessment. All patients should complete an End of Study visit within 28 days after the last dose of study drug and prior to the start of alternate antineoplastic therapy.
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): NCT01621542
|United States, Arizona|
|The University of Arizona Cancer Center - North Campus|
|Tucson, Arizona, United States, 85719|
|United States, California|
|UC San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|United States, Illinois|
|The University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|The University of Texas, MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Director:||Vice President Clinical Development and Medical Affairs, MD||Sunovion|