A Study of BI 853520 in Japanese and Taiwanese Patients With Various Types of Advanced or Metastatic Cancer
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Drug: BI 853520
- Registration Number
- NCT01905111
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BI 853520 BI 853520 BI 853520 once daily in a dose escalation schedule
- Primary Outcome Measures
Name Time Method Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient After the first 28 days of treatment
- Secondary Outcome Measures
Name Time Method Objective response rate Every 8 weeks until end of study participation, assessed up to 12 months Disease control rate Every 8 weeks until end of study participation, assessed up to 12 months Duration of disease control 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 Every 8 weeks until end of study participation, assessed up to 12 months
Trial Locations
- Locations (2)
1300.15.88601 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1300.15.81001 Boehringer Ingelheim Investigational Site
🇯🇵Kashiwa-shi, Chiba, Japan