Ignite Creation Date:
2024-05-06 @ 1:04 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01720173
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2012-10-30
Brief Title:
Dalantercept in Treating Patients With Recurrent Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cavity Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Dalantercept NSC 757172 a Novel Soluble Recombinant Activin Receptor-Like Kinase 1 ALK-1 Inhibitor Receptor-Fusion Protein in the Treatment of Persistent or Recurrent Epithelial Ovarian Fallopian Tube or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2021-09
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 the side effects and how well dalantercept works in treating patients with ovarian epithelial fallopian tube or primary peritoneal cavity cancer that has returned Dalantercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Dalantercept may also stop the growth of tumor cells by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the proportion of patients who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response complete or partial in patients with persistent or recurrent epithelial ovarian fallopian tube or primary peritoneal carcinoma treated with dalantercept
II To determine the frequency and severity of adverse events associated with treatment with dalantercept as assessed by the Active Version of the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE
SECONDARY OBJECTIVES
I To determine the duration of progression-free survival PFS and overall survival OS
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-B activin receptor-like kinase 1 ALK1 cluster of differentiation 105 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 BMP9 BMP10 and ALK1 in pre-cycle 1 plasma using an enzyme-linked immunosorbent assay ELISA and clinical response to treatment
OUTLINE
Patients receive dalantercept subcutaneously SC on day 1 Courses repeat every 3 weeks 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 who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response complete or partial in patients with persistent or recurrent epithelial ovarian fallopian tube or primary peritoneal carcinoma treated with dalantercept
II To determine the frequency and severity of adverse events associated with treatment with dalantercept as assessed by the Active Version of the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE
SECONDARY OBJECTIVES
I To determine the duration of progression-free survival PFS and overall survival OS
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-B activin receptor-like kinase 1 ALK1 cluster of differentiation 105 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 BMP9 BMP10 and ALK1 in pre-cycle 1 plasma using an enzyme-linked immunosorbent assay ELISA and clinical response to treatment
OUTLINE
Patients receive dalantercept subcutaneously SC on day 1 Courses repeat every 3 weeks 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-01936 | REGISTRY | None | None |
| NSC 757172 | None | None | None |
| CDR0000742512 | None | None | None |
| GOG-0170R | OTHER | None | None |
| GOG-0170R | OTHER | None | None |
| U10CA180868 | NIH | None | None |