The primary objective of this trial is:
Part I
The secondary objectives are:
Part I
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neoplasms | Drug: BI 836880 Drug: BI 754091 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 21 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open Label, Phase I Study of BI 836880 Monotherapy and Combination Therapy of BI 836880 and BI 754091 in Japanese Patients With Advanced Solid Tumours |
| Actual Study Start Date : | June 12, 2019 |
| Actual Primary Completion Date : | October 27, 2020 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Part I: BI 836880 alone
Part I followed by Part II
|
Drug: BI 836880
Solution for infusion
|
| Experimental: Part II: BI 836880 and BI 754091 |
Drug: BI 836880
Solution for infusion
Drug: BI 754091 Solution for infusion
|
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Any of the following laboratory evidence of hepatitis virus infection.
Uncontrolled hypertension is defined as follows: Blood pressure in rested and relaxed condition ≥140 mmHg, systolic or ≥90 mmHg diastolic (with or without medication)
| Japan | |
| Shizuoka Cancer Center | |
| Shizuoka, Sunto-gun, Japan, 411-8777 | |
| National Cancer Center Hospital | |
| Tokyo, Chuo-ku, Japan, 104-0045 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 31, 2019 | ||||
| First Posted Date ICMJE | June 3, 2019 | ||||
| Last Update Posted Date | June 7, 2021 | ||||
| Actual Study Start Date ICMJE | June 12, 2019 | ||||
| Actual Primary Completion Date | October 27, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Find the Best Dose of BI 836880 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer | ||||
| Official Title ICMJE | An Open Label, Phase I Study of BI 836880 Monotherapy and Combination Therapy of BI 836880 and BI 754091 in Japanese Patients With Advanced Solid Tumours | ||||
| Brief Summary |
The primary objective of this trial is: Part I
The secondary objectives are: Part I
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Neoplasms | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Actual Enrollment ICMJE |
21 | ||||
| Original Estimated Enrollment ICMJE |
24 | ||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
| Actual Primary Completion Date | October 27, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion criteria:
Uncontrolled hypertension is defined as follows: Blood pressure in rested and relaxed condition ≥140 mmHg, systolic or ≥90 mmHg diastolic (with or without medication)
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| Sex/Gender ICMJE |
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| Ages ICMJE | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Japan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03972150 | ||||
| Other Study ID Numbers ICMJE | 1336-0012 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Boehringer Ingelheim | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Boehringer Ingelheim | ||||
| Verification Date | June 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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