Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01876043
Status:
TERMINATED
Last Update Posted:
2021-01-25
First Post:
2012-10-29
Brief Title:
Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic RelapsedRefractory Dedifferentiated Liposarcoma DLPS an Exploratory Phase II Multicenter Trial
Sponsor:
Institut Bergonié
Organization:
Institut Bergonié
Study Overview
Official Title:
Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic RelapsedRefractory Dedifferentiated Liposarcoma DLPS an Exploratory Phase II Multicenter Trial
Status:
TERMINATED
Status Verified Date:
2020-12
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:
APLIPO
Brief Summary:
Liposarcomas are soft tissue sarcomas most frequent We distinguish three subtypes on the basis of their histological and cytogenetic characteristics well-differentiated liposarcoma dedifferentiated myxoid liposarcoma and or round cell liposarcoma and pleomorphic Dedifferentiated liposarcomas LDD represent 20 of liposarcomas and are characterized by well-differentiated component associated with a contingent sarcomatous differentiation and fat-usually high grade The LDD are most often rétropértionéal seat Thus their development is very long asymptomatic At diagnosis tumor volume is often very important making surgical removal impossible in a high proportion of cases Operable tumors have also a risk of local recurrence by about 50 and about 20 metastatic Chemotherapy is the only treatment of these advanced forms However the currently available drugs adriamycin ifosfamide have only very limited effectiveness Progression-free survival of patients does not exceed 2 months The LDD is characterized cytogenetically by the constant presence of two amplicons 1p32 and 6q23 respectively targeting genes MAP3K5 and JUN These two genes encode proteins involved in the signaling pathway Jun N-terminal kinase JNK Activation of JNK is involved in the loss of adipose differentiation and tumor aggressiveness of LDD The plitidepsin is a drug capable of inducing apoptosis of tumor cells carrying a functional activation of the JNK pathway This drug has such a pro-apoptotic and anti-proliferative in vitro models of LDD plitidepsin could represent the treatment of choice for patients with advanced LDD The objective of this study is to evaluate the anti-tumor activity of plitidepsin patients with locally advanced dedifferentiated liposarcomas and or metastatic
Detailed Description:
None
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