Study of ENMD-2076 in Patients With Advanced/Metastatic Soft Tissue Sarcoma
|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: NCT01719744|
Recruitment Status : Completed
First Posted : November 1, 2012
Results First Posted : November 7, 2017
Last Update Posted : June 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Metastatic Soft Tissue Sarcoma||Drug: ENMD-2076||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oral ENMD-2076 Administered to Patients With Advanced/Metastatic Soft Tissue Sarcoma|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
ENMD-2076 capsules, 275 mg once daily, by mouth.
- 6-month Progression-free Survival Rate (PFS) [ Time Frame: From start of study treatment until disease progression or death, whichever occurs first, up to 6 months. ]Number of patients with no progression of disease at 6 months
- Number of and Severity of Adverse Events Per Participant [ Time Frame: 2 years ]Number of participants who experienced a grade 3 or higher adverse event. Reporting threshold 5%
- Objective Response Rate [ Time Frame: From start of study treatment until disease progression or death, whichever occurs first. ]
Objective Response Rate (ORR) = CR+ PR. ORR is evaluated per RECIST v1.1 criteria.
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
- Number of Certain Biomarkers in Participants Compared to Progression Free Survival. [ Time Frame: 2 years ]
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): NCT01719744
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Albiruni Razak, MBBS||Princess Margaret Cancer Centre|