A Study of BI 853520 in Patients With Various Types of Advanced or Metastatic Cancer
This study has been completed.
Information provided by (Responsible Party):
First received: April 7, 2011
Last updated: December 8, 2015
Last verified: December 2015
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.
Drug: BI 853520
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
- Cmax (maximum measured concentration of the analyte in plasma) after first dose [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
- AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after the last dose in cycle 1 [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
- AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the last dose in cycle 1 [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
- Disease control rate (CR or PR or SD per RECIST v1.1) ) [ Time Frame: up to 39 months ] [ Designated as safety issue: No ]
- Duration of disease control (measured from drug start date to the date of disease progression for patients who had CR or PR or SD during treatment) [ Time Frame: up to 39 months ] [ Designated as safety issue: No ]
- Objective response rate (CR or PR per RECIST v1.1) [ Time Frame: up to 39 months ] [ Designated as safety issue: No ]
- Tumour shrinkage (in millimetre) defined as change from baseline to the minimum post-baseline sum of diameters of target lesions. [ Time Frame: up to 39 months ] [ Designated as safety issue: No ]
- Pharmacodynamic assessment: phosphorylated and total PTK2 (FAK) modulation in tumour biopsies [ Time Frame: baseline, day 22 and day 28 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
Experimental: Treatment arm
BI 853520 once daily in a dose escalation schedule
Drug: BI 853520
BI 853520 once daily in a dose escalation schedule
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with a confirmed diagnosis of advanced, measurable or evaluable, nonresectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months as demonstrated by serial imaging
- Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
- Tumour tissue must be available for the determination of E-cadherin expression (archived tissue or fresh biopsy).
- Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (CTCAE grade < 2)
- Age = 18 years
- Life expectancy = 3 months
- Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation, including consent for PK samples, for using an archived tumour sample for determination of Ecadherin status, for reviewing previous tumour scans (and for providing skin biopsies, in patients in dose finding phase enrolled before protocol amendment 03)
Eastern Cooperative Oncology Group (ECOG), R01-0787) performance score 0-1
Additional inclusion criteria in the expansion phase:
- Patients must have measurable progressive disease within the last 6 months, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1, R09-0262)
- Patients must be willing to provide paired tumour biopsies for PD determination. Refer to section 5.6.3
- Patients should fit into one of the categories described below:
I. Metastatic adenocarcinoma of the pancreas Patients should have preferably received at least one line of systemic treatment for metastatic disease and preferably not more than 2 prior regimens for metastatic disease.
II. Platinum-resistant ovarian carcinoma, defined as recurrence within 6 months after completion of prior platinum-based chemotherapy Patients should have received preferably no more than 5 previous lines of systemic treatment for metastatic disease.
III. Oesophageal carcinoma Patients with oesophageal carcinoma of adenocarcinoma- or squamous cell histology who have received preferably not more than 2 previous lines of systemic treatment for metastatic disease.
IV. Soft tissue sarcoma Patients should preferably have received no more than 2 previous lines of systemic treatment for metastatic disease.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335269
|1300.2.1002 Boehringer Ingelheim Investigational Site
|Hamilton, Ontario, Canada |
|1300.2.1001 Boehringer Ingelheim Investigational Site
|Toronto, Ontario, Canada |
|1300.2.31003 Boehringer Ingelheim Investigational Site
|Amsterdam, Netherlands |
|1300.2.31001 Boehringer Ingelheim Investigational Site
|Rotterdam, Netherlands |
|1300.2.31002 Boehringer Ingelheim Investigational Site
|Utrecht, Netherlands |
ClinicalTrials.gov processed this record on May 26, 2016
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 7, 2011
||December 8, 2015
||Canada: Health Canada
Netherlands: Central Committee Research Involving Human Subjects