NeoplasmsPhase 1NCT01905111
A Study of BI 853520 in Japanese and Taiwanese 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 2 sites in 2 countries.
Trial summary
The primary objective of this trial is to explore the safety and tolerability of BI 853520 monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese patients with advanced or metastatic solid tumours. Secondary objective is collection of preliminary data on anti-tumour efficacy Read more about this study
- Who is it for?
- Ages 20 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
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2013to Aug 2014
- 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 20 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, 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 >= 20 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
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
2 sites in 2 countries.
2 sites in 2 countries
Japan1 site
1300.15.81001 Boehringer Ingelheim Investigational Site
Kashiwa-shi, Chiba
About this study
Official title: An Open-label Phase I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Japanese and Taiwanese Patients With Various Advanced or Metastatic Solid Tumours
The primary objective of this trial is to explore the safety and tolerability of BI 853520 monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese patients with advanced or metastatic solid tumours.
Secondary objective is 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 |
|---|---|---|
| BI 853520 | 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
Measured: After the first 28 days of treatment
Secondary outcomes (4)
Objective response rate
Measured: Every 8 weeks until end of study participation, assessed up to 12 months
Disease control rate
Measured: Every 8 weeks until end of study participation, assessed up to 12 months
Duration of disease control
Measured: Every 8 weeks until end of study participation, assessed up to 12 months
Tumour shrinkage (in millimetre) defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of longest diameters of the same set of target lesions
Measured: Every 8 weeks until end of study participation, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 21 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
- NCT01905111
- Sponsor's protocol ID
- 1300.15
- Status last verified
- Sep 2014
- First submitted
- 12 Jul 2013
- Last updated
- 4 Sep 2014
- Results posted
- No
Publications
Doi T, Yang JC, Shitara K, Naito Y, Cheng AL, Sarashina A, Pronk LC, Takeuchi Y, Lin CC. Phase I Study of the Focal Adhesion Kinase Inhibitor BI 853520 in Japanese and Taiwanese Patients with Advanced or Metastatic Solid Tumors. Target Oncol. 2019 Feb;14(1):57-65. doi: 10.1007/s11523-019-00620-0.
PubMed 30725402
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. 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 Japanese and Taiwanese Patients With Various Advanced or Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT01905111
- Acronym / sponsor ID
- 1300.15
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Jul 2013 (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 explore the safety and tolerability of BI 853520 monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese patients with advanced or metastatic solid tumours.
Secondary objective is 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 |
|---|---|---|
| BI 853520 | Experimental | Drug: BI 853520BI 853520 once daily in a dose escalation schedule |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 >= 20 years
- Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation
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 | BI 853520 |
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
Time frame: After the first 28 days of treatment
4 secondary outcomes
Objective response rate
Time frame: Every 8 weeks until end of study participation, assessed up to 12 months
Disease control rate
Time frame: Every 8 weeks until end of study participation, assessed up to 12 months
Duration of disease control
Time frame: Every 8 weeks until end of study participation, assessed up to 12 months
Tumour shrinkage (in millimetre) defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of longest diameters of the same set of target lesions
Time frame: Every 8 weeks until end of study participation, assessed up to 12 months
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 4 Sep 2014.
- Derived from this study: PubMed 30725402Doi T, Yang JC, Shitara K, Naito Y, Cheng AL, Sarashina A, Pronk LC, Takeuchi Y, Lin CC. Phase I Study of the Focal Adhesion Kinase Inhibitor BI 853520 in Japanese and Taiwanese Patients with Advanced or Metastatic Solid Tumors. Target Oncol. 2019 Feb;14(1):57-65. doi: 10.1007/s11523-019-00620-0.
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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
2 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 2 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 6 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 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan, Taiwan. 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 (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 NCT01905111, which also lists 1 linked publication.
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 4 Sep 2014.