Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-30 @ 5:14 PM
Study NCT ID:
NCT01335269
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2011-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BI 853520 in Patients With Various Types of Advanced or Metastatic Cancer
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
An Open Label Phase I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Patients With Various Advanced or Metastatic Non-hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2015-12
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 this trial is to determine the safety and tolerability of BI 853520 monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for further trials in the development of this compound.
Secondary objectives are
* determination of the pharmacokinetic (PK) profile;
* exploratory pharmacodynamic analysis; and
* collection of preliminary data on anti-tumour efficacy.
Secondary objectives are
* determination of the pharmacokinetic (PK) profile;
* exploratory pharmacodynamic analysis; and
* collection of preliminary data on anti-tumour efficacy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-024609-10 | EUDRACT_NUMBER | EudraCT | View |