Ignite Creation Date:
2024-05-06 @ 12:43 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01642082
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2012-07-15
Brief Title:
Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Dalantercept a Novel Soluble Recombinant Activin Receptor-Like Kinase 1 ALK-1 Inhibitor Receptor-Fusion Protein in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-05
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 phase II trial studies how well dalantercept works in treating patients with endometrial cancer that has come back or is persistent Dalantercept may stop the growth of endometrial cancer by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the proportion of patients with persistent or recurrent endometrial cancer who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response complete or partial treated with dalantercept ACE-041
II To determine the nature and degree of toxicity of dalantercept in this cohort of patients
SECONDARY OBJECTIVES
I To estimate progression-free survival PFS and overall survival OS of patients with persistent or recurrent endometrial cancer treated with dalantercept
TERTIARY OBJECTIVES
I To measure the expression of vascular endothelial growth factor VEGF fibroblast growth factor FGF platelet-derived growth factor PDGF transforming growth factor-beta TGF-β activin receptor-like kinase 1 ALK1 endoglin CD105 and other markers via immunohistochemistry IHC and determine if there is correlation between expression and clinical response to treatment
II To determine the correlation between ALK1 gene expression other markers and clinical response to treatment
III To determine the correlation between concentration of VEGF bone morphogenetic protein 9 BMP9 bone morphogenetic protein 10 BMP10 and ALK1 in pre-cycle 1 plasma using an enzyme-linked immunosorbent assay ELISA and clinical response to treatment
IV To correlate somatic mutations in candidate genes with response to therapy
OUTLINE
Patients receive dalantercept subcutaneously SC on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
I To estimate the proportion of patients with persistent or recurrent endometrial cancer who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response complete or partial treated with dalantercept ACE-041
II To determine the nature and degree of toxicity of dalantercept in this cohort of patients
SECONDARY OBJECTIVES
I To estimate progression-free survival PFS and overall survival OS of patients with persistent or recurrent endometrial cancer treated with dalantercept
TERTIARY OBJECTIVES
I To measure the expression of vascular endothelial growth factor VEGF fibroblast growth factor FGF platelet-derived growth factor PDGF transforming growth factor-beta TGF-β activin receptor-like kinase 1 ALK1 endoglin CD105 and other markers via immunohistochemistry IHC and determine if there is correlation between expression and clinical response to treatment
II To determine the correlation between ALK1 gene expression other markers and clinical response to treatment
III To determine the correlation between concentration of VEGF bone morphogenetic protein 9 BMP9 bone morphogenetic protein 10 BMP10 and ALK1 in pre-cycle 1 plasma using an enzyme-linked immunosorbent assay ELISA and clinical response to treatment
IV To correlate somatic mutations in candidate genes with response to therapy
OUTLINE
Patients receive dalantercept subcutaneously SC on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0229N | None | None | None |
| CDR0000736764 | None | None | None |
| NCI-2012-01986 | REGISTRY | None | None |
| GOG-0229N | OTHER | None | None |
| GOG-0229N | OTHER | None | None |
| U10CA180868 | NIH | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |