Efficacy and Safety Study of GPX-150 to Treat Soft Tissue Sarcoma
|ClinicalTrials.gov Identifier: NCT02267083|
Recruitment Status : Completed
First Posted : October 17, 2014
Results First Posted : January 10, 2018
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: GPX-150 for Injection||Phase 2|
This is an open-label, single arm study of GPX-150 in patients with soft tissue sarcoma. Approximately 22 patients will be treated in this study. The population for this study is adult patients with histologically proven advanced and/or metastatic malignant soft tissue sarcoma of intermediate or high histologic grade.
All patients who meet all entry criteria will receive GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity or subject withdrawal.
Prior to initiation of treatment, subjects will undergo screening and baseline evaluations. During all study visits, subjects will be evaluated for safety. The dose of GPX-150 may be reduced when subjects meet specified dose reduction safety criteria. Subjects will be evaluated regularly for safety and tolerability. Tumor measurements will be calculated at baseline (within 28 days prior to treatment initiation), then at regular intervals while receiving treatment for up to 1 year. After discontinuing the treatment phase of the study, safety assessments and tumor measurements will be performed 3 weeks after the last dose of study drug.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Efficacy and Safety Study of Intravenous GPX-150, an Anthracycline Analog, in Patients With Soft Tissue Sarcoma|
|Study Start Date :||January 7, 2015|
|Actual Primary Completion Date :||November 11, 2015|
|Actual Study Completion Date :||August 18, 2016|
GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.
Drug: GPX-150 for Injection
GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study.
- Number of Subjects Progression-free at 12 Months Per RECIST 1.1 [ Time Frame: 12 months from the beginning of study treatment ]The primary efficacy endpoint is the number of patients who were progression-free at 12 months, which is obtained by inversion of the Kaplan-Meier curve for progression-free survival (PFS) at 12 months. Of note, the statistical comparison to historical sarcoma data described in the protocol was not performed due to an enrollment of less than the planned sample size of 30 subjects. Progression is defined using RECIST 1.1, as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
- Number of Subjects Progression-free at Six Months Per RECIST 1.1 [ Time Frame: 6 months from the beginning of the study treatment ]This secondary efficacy endpoint is the progression-free rate (PFR) at 6 months, obtained from the Kaplan-Meier curve for progression-free survival (PFS).
- Number of Subjects Experiencing Adverse Events [ Time Frame: From the beginning of study treatment and up to 12 months ]Subjects who received at least one dose were included in safety analyses. Adverse events were tabulated by System Organ Class (SOC) and Preferred Term (PT) and coded using MedDRA Version 19.1. Safety and tolerability was determined by frequency, nature, and severity of adverse events and the profile of toxicities.
- Number of Subjects With Tumor Response Per RECIST 1.1 [ Time Frame: Assessed during screening, then every 6 weeks for the first 24 weeks on study, and then every 9 weeks for the next 24 weeks for up to 1 year. Subjects will be in the study for up to 1 year, or until disease progression or unacceptable toxicity. ]Tumor assessments using contrast enhanced computerized tomography (CT) scan of the Chest/Abdomen/Pelvis were performed to assess overall tumor burden. Response rate (RR), where response is defined as complete response (CR), partial response (PR), or stable disease (SD). Determination of CR or PR requires confirmation at the time of the next tumor assessment. An outcome of SD requires at least one assessment 6 weeks after the initiation of dosing. Progression is defined using RECIST 1.1, as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267083
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Iowa|
|University of Iowa Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Pennsylvania|
|Penn State Milton S Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Mohammed Milhem, MD||University of Iowa Holden Comprehensive Cancer Center|