NeoplasmsPhase 1NCT01335269
A Study of BI 853520 in Patients With Various Types of Advanced or Metastatic Cancer
A Phase 1 study testing BI 853520 in people with Neoplasms, run by Boehringer Ingelheim at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BI 853520
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jul 2011to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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)
- deleted
- 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:
- 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.
- 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.
- 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.
- Soft tissue sarcoma Patients should preferably have received no more than 2 previous lines of systemic treatment for metastatic disease.
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Netherlands3 sites
1300.2.31003 Boehringer Ingelheim Investigational Site
Amsterdam
1300.2.31001 Boehringer Ingelheim Investigational Site
Rotterdam
1300.2.31002 Boehringer Ingelheim Investigational Site
Utrecht
Canada2 sites
1300.2.1002 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1300.2.1001 Boehringer Ingelheim Investigational Site
Toronto, Ontario
About this study
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
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.
- Conditions
- Neoplasms
- Being tested
- BI 853520
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 853520Drug
BI 853520 once daily in a dose escalation schedule
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | BI 853520 once daily in a dose escalation schedule Receives: Drug: BI 853520 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After the first 28 days of treatment
Secondary outcomes (9)
Cmax (maximum measured concentration of the analyte in plasma) after first dose
Measured: up to 48 hours
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)
Measured: up to 48 hours
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
Measured: up to 24 hours
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
Measured: up to 24 hours
Disease control rate (CR or PR or SD per RECIST v1.1) )
Measured: up to 39 months
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)
Measured: up to 39 months
Objective response rate (CR or PR per RECIST v1.1)
Measured: up to 39 months
Tumour shrinkage (in millimetre) defined as change from baseline to the minimum post-baseline sum of diameters of target lesions.
Measured: up to 39 months
Pharmacodynamic assessment: phosphorylated and total PTK2 (FAK) modulation in tumour biopsies
Measured: baseline, day 22 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335269
- Sponsor's protocol ID
- 1300.2
- Other IDs
- 2010-024609-10
- Status last verified
- Dec 2015
- First submitted
- 7 Apr 2011
- Last updated
- 9 Dec 2015
- Results posted
- No
Publications
Fard D, Giraudo E, Tamagnone L. Mind the (guidance) signals! Translational relevance of semaphorins, plexins, and neuropilins in pancreatic cancer. Trends Mol Med. 2023 Oct;29(10):817-829. doi: 10.1016/j.molmed.2023.07.009. Epub 2023 Aug 17.
PubMed 37598000de Jonge MJA, Steeghs N, Lolkema MP, Hotte SJ, Hirte HW, van der Biessen DAJ, Abdul Razak AR, De Vos FYFL, Verheijen RB, Schnell D, Pronk LC, Jansen M, Siu LL. Phase I Study of BI 853520, an Inhibitor of Focal Adhesion Kinase, in Patients with Advanced or Metastatic Nonhematologic Malignancies. Target Oncol. 2019 Feb;14(1):43-55. doi: 10.1007/s11523-018-00617-1.
PubMed 30756308Verheijen RB, van der Biessen DAJ, Hotte SJ, Siu LL, Spreafico A, de Jonge MJA, Pronk LC, De Vos FYFL, Schnell D, Hirte HW, Steeghs N, Lolkema MP. Randomized, Open-Label, Crossover Studies Evaluating the Effect of Food and Liquid Formulation on the Pharmacokinetics of the Novel Focal Adhesion Kinase (FAK) Inhibitor BI 853520. Target Oncol. 2019 Feb;14(1):67-74. doi: 10.1007/s11523-018-00618-0.
PubMed 30742245
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01335269
- Acronym / sponsor ID
- 1300.2
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: BI 853520BI 853520 once daily in a dose escalation schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 853520BI 853520 once daily in a dose escalation schedule | Drug | Treatment arm |
Primary outcome
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
9 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma) after first dose
Time frame: up to 48 hours
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
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
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
Disease control rate (CR or PR or SD per RECIST v1.1) )
Time frame: up to 39 months
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
Objective response rate (CR or PR per RECIST v1.1)
Time frame: up to 39 months
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
Pharmacodynamic assessment: phosphorylated and total PTK2 (FAK) modulation in tumour biopsies
Time frame: baseline, day 22 and day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Derived from this study: PubMed 37598000Fard D, Giraudo E, Tamagnone L. Mind the (guidance) signals! Translational relevance of semaphorins, plexins, and neuropilins in pancreatic cancer. Trends Mol Med. 2023 Oct;29(10):817-829. doi: 10.1016/j.molmed.2023.07.009. Epub 2023 Aug 17.
- Derived from this study: PubMed 30756308de Jonge MJA, Steeghs N, Lolkema MP, Hotte SJ, Hirte HW, van der Biessen DAJ, Abdul Razak AR, De Vos FYFL, Verheijen RB, Schnell D, Pronk LC, Jansen M, Siu LL. Phase I Study of BI 853520, an Inhibitor of Focal Adhesion Kinase, in Patients with Advanced or Metastatic Nonhematologic Malignancies. Target Oncol. 2019 Feb;14(1):43-55. doi: 10.1007/s11523-018-00617-1.
- Derived from this study: PubMed 30742245Verheijen RB, van der Biessen DAJ, Hotte SJ, Siu LL, Spreafico A, de Jonge MJA, Pronk LC, De Vos FYFL, Schnell D, Hirte HW, Steeghs N, Lolkema MP. Randomized, Open-Label, Crossover Studies Evaluating the Effect of Food and Liquid Formulation on the Pharmacokinetics of the Novel Focal Adhesion Kinase (FAK) Inhibitor BI 853520. Target Oncol. 2019 Feb;14(1):67-74. doi: 10.1007/s11523-018-00618-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 853520 in people with Neoplasms, run by Boehringer Ingelheim at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01335269, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.