Ignite Creation Date:
2024-05-05 @ 11:09 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01262235
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2010-12-15
Brief Title:
A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors NET and Adrenocortical Carcinoma ACC Patients
Sponsor:
Arbutus Biopharma Corporation
Organization:
Arbutus Biopharma Corporation
Study Overview
Official Title:
A Phase 12 Dose Escalation Study to Determine the Safety Pharmacokinetics and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-01
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 be a Phase III open-label non-randomized dose-finding trial conducted at multiple clinical centers The study is designed to determine the safety tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors NET or adrenocortical carcinoma ACC tumors
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