Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01950273
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2013-09-23
Brief Title:
Pharmacokinetics and Pharmacodynamics of BI 695500 vs Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomized Double-blind Parallel-arm Phase I Study to Evaluate the Pharmacokinetics and Pharmacodynamics of BI 695500 vs Rituximab MabThera Induction Immunotherapy as a First-line Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-08
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:
The primary objective of the study is to assess the pharmacokinetic PK similarity of Boehringer Ingelheim BI 695500 vs rituximab MabThera in previously untreated patients with low tumor burden follicular lymphoma LTBFL
The secondary objective of the study is to evaluate the pharmacodynamics PD safety and anti-tumor activity of BI 695500 vs rituximab MabThera as well as the presence of anti-drug antibodies ADAs
The secondary objective of the study is to evaluate the pharmacodynamics PD safety and anti-tumor activity of BI 695500 vs rituximab MabThera as well as the presence of anti-drug antibodies ADAs
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-001904-12 | EUDRACT_NUMBER | None | None |