Weekly BI 836880 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02689505|
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Last Update Posted : April 19, 2019
This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously once a week. The eligible patient population will be patients with advanced solid tumors.
The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety data will be evaluated as secondary objectives.
Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid tumors.
Dose escalation will be guided by a Bayesian logistic regression model with over dose control (EWOC) using at least 2 patients per dose cohorts.
Safety criteria will be followed, including adverse events according to Common Terminology Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination, vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: BI 836880||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 836880 Administered by Weekly Repeated Intravenous Infusions in Patients With Advanced Solid Tumors.|
|Actual Study Start Date :||April 4, 2016|
|Estimated Primary Completion Date :||June 28, 2019|
|Estimated Study Completion Date :||August 9, 2019|
|Experimental: BI 836880||
Drug: BI 836880
- The primary endpoint is to determine the maximum tolerated dose (MTD) based on the number of patients presenting dose limiting toxicity (DLT) using CTCAE V4.03, during the first course and judged to be related to the study medication [ Time Frame: up to 6 months ]
- Drug related Adverse Events (AEs) leading to dose reduction or discontinuation during treatment period [ Time Frame: up to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689505
|CTR Georges-François Leclerc|
|Dijon, France, 21079|
|Hospital Vall d'Hebron|
|Barcelona, Spain, 08035|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|