A Study of BI 853520 in Patients With Various Types of Advanced or Metastatic Cancer
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01335269
First received: April 7, 2011
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: BI 853520 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient in the dose finding phase [ Time Frame: After the first 28 days of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic parameters of BI 853520 will be determined from plasma analyses after a single oral dose and after repeated dosing, at steady state: Cmax and Area Under the Curve [ Time Frame: During first 28 days of treatment ] [ Designated as safety issue: No ]
- Pharmacodynamic assessment: pPTK2 modulation pre- and post treatment in skin or tumor [ Time Frame: During the first 28 days of treatment ] [ Designated as safety issue: No ]
- Exploratory evaluation of efficacy (e.g. objective response rate, disease control rate, duration of disease control, tumor shrinkage) [ Time Frame: Every 8 weeks until end of study participation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment arm
BI 853520 once daily in a dose escalation schedule
|
Drug: BI 853520
BI 853520 once daily in a dose escalation schedule
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients with a confirmed diagnosis of advanced, measurable or evaluable, non-resectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months
- Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
- Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (Common Terminology Criteria for Adverse Events grade <2)
- Age >= 18 years
- Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation
- Eastern Cooperative Oncology Group (ECOG), performance score 0-1
Exclusion criteria:
- Serious concomitant non-oncological disease/illness
- Active/symptomatic brain metastases
- Second malignancy
- Pregnancy or breastfeeding
- Women or men who are sexually active and unwilling to use a medically acceptable method of contraception.
- Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335269
Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Locations
| Canada, Ontario | |
| 1300.2.1002 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Hamilton, Ontario, Canada | |
| 1300.2.1001 Boehringer Ingelheim Investigational Site | Recruiting |
| Toronto, Ontario, Canada | |
| Netherlands | |
| 1300.2.31001 Boehringer Ingelheim Investigational Site | Recruiting |
| Rotterdam, Netherlands | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01335269 History of Changes |
| Other Study ID Numbers: | 1300.2, 2010-024609-10 |
| Study First Received: | April 7, 2011 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Canada: Health Canada Netherlands: |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013