Ignite Creation Date:
2024-05-06 @ 7:39 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02572453
Status:
TERMINATED
Last Update Posted:
2022-09-13
First Post:
2015-10-08
Brief Title:
Phase 2 Study of AT13387 Onalespib in ALK ALCL MCL and BCL-6 DLBCL
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 2 Trial of the Heat Shock Protein-90 Hsp90 Inhibitor AT13387 Onalespib in Patients With RelapsedRefractory ALK ALCL Mantle Cell Lymphoma and BCL6 DLBCL
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug supply issues
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 onalespib works in treating patients with anaplastic large cell lymphoma mantle cell lymphoma or diffuse large B-cell lymphoma that has not responded to previous treatment refractory or that has returned after a period of improvement recurrent Onalespib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVE
I Overall response rate ORR to single agent AT13387 onalespib as measured by the proportion of partial and complete responses PR CR in patients with relapsedrefractory ALK positive anaplastic large cell lymphoma ALCL mantle cell lymphoma MCL and BCL6 diffuse large B cell lymphoma DLBCL
SECONDARY OBJECTIVES
I Progression free survival PFS and overall survival OS as well as duration of response DOR of single agent AT13387 onalespib in patients with ALK ALCL MCL and BCL6 DLBCL
II Safety and tolerability of single agent AT13387 onalespib in patients with ALK ALCL MCL and BCL6 DLBCL
EXPLORATORY OBJECTIVES
I Measurement of on-target activity of AT13387 onalespib in ALK ALCL MCL and BCL6 DLBCL through immunoblotting and immunohistochemistry of pre-treatment on-treatment and time of progression tumor biopsies for HSP90 clients
II Determination of genetic and transcriptional markers for response and resistance to AT13387 onalespib in patients with ALK ALCL MCL and BCL6 DLBCL
OUTLINE
Patients receive onalespib intravenously IV over 1 hour on days 1 2 8 9 15 and 16 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for up to 1 year
I Overall response rate ORR to single agent AT13387 onalespib as measured by the proportion of partial and complete responses PR CR in patients with relapsedrefractory ALK positive anaplastic large cell lymphoma ALCL mantle cell lymphoma MCL and BCL6 diffuse large B cell lymphoma DLBCL
SECONDARY OBJECTIVES
I Progression free survival PFS and overall survival OS as well as duration of response DOR of single agent AT13387 onalespib in patients with ALK ALCL MCL and BCL6 DLBCL
II Safety and tolerability of single agent AT13387 onalespib in patients with ALK ALCL MCL and BCL6 DLBCL
EXPLORATORY OBJECTIVES
I Measurement of on-target activity of AT13387 onalespib in ALK ALCL MCL and BCL6 DLBCL through immunoblotting and immunohistochemistry of pre-treatment on-treatment and time of progression tumor biopsies for HSP90 clients
II Determination of genetic and transcriptional markers for response and resistance to AT13387 onalespib in patients with ALK ALCL MCL and BCL6 DLBCL
OUTLINE
Patients receive onalespib intravenously IV over 1 hour on days 1 2 8 9 15 and 16 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for up to 1 year
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 |
|---|---|---|---|
| UM1CA186709 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186709 |
| NCI-2015-01681 | REGISTRY | None | None |
| 16-712 | None | None | None |
| 9875 | OTHER | None | None |
| 9875 | OTHER | None | None |
| UM1CA186690 | NIH | None | None |