Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02267083
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2014-09-23
Brief Title:
Efficacy and Safety Study of GPX-150 to Treat Soft Tissue Sarcoma
Sponsor:
Gem Pharmaceuticals
Organization:
Gem Pharmaceuticals
Study Overview
Official Title:
Phase 2 Efficacy and Safety Study of Intravenous GPX-150 an Anthracycline Analog in Patients With Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the safety and efficacy of GPX-150 administered intravenously every 3 weeks in the treatment of patients with soft tissue sarcoma
Detailed Description:
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 andor 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 mgm2 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
All patients who meet all entry criteria will receive GPX-150 at a starting dose of 265 mgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None