Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
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|ClinicalTrials.gov Identifier: NCT00950742|
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : October 17, 2013
Last Update Posted : July 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Trastuzumab Drug: BIBW 2992||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Open Label Trial to Assess Safety of BIBW 2992 in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: BIBW 2992 + Trastuzumab
Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally with fixed weekly infusion doses of 2mg/kg Herceptin. Escalating doses of BIBW 2992 starting at 20mg daily.
Drug: BIBW 2992
Increased dose cohorts from low dose to MTD
- Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: 28 days ]Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.
- Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R) [ Time Frame: 28 days ]The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.
- Number of Patients With Objective Response (OR) [ Time Frame: Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment. ]Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).
- Number of Patients With Best Overall Response [ Time Frame: Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment. ]Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable.
- Progression Free Survival (PFS) [ Time Frame: Baseline until disease progression, death or data cut-off. ]PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.
- Summary of Concentration of Afatinib in Plasma [ Time Frame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing ]Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss).
- Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) [ Time Frame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing ]tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state
- Summary of Concentration of Herceptin in Plasma [ Time Frame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing ]Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29).
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): NCT00950742
|1200.68.44001 Boehringer Ingelheim Investigational Site|
|Brighton, United Kingdom|
|1200.68.44003 Boehringer Ingelheim Investigational Site|
|Cambridge, United Kingdom|
|1200.68.44005 Boehringer Ingelheim Investigational Site|
|Guildford, United Kingdom|
|1200.68.44004 Boehringer Ingelheim Investigational Site|
|Newcastle upon Tyne, United Kingdom|
|1200.68.44002 Boehringer Ingelheim Investigational Site|
|Truro, United Kingdom|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|