BI 6727 (Volasertib) Monotherapy Phase I Trial in Japanese Patients With Advanced Solid Tumours
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|ClinicalTrials.gov Identifier: NCT01348347|
Recruitment Status : Completed
First Posted : May 5, 2011
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: Volasertib, low dose, d1q3w Drug: Volasertib, middle dose, d1q3w Drug: Volasertib, high dose, d1q3w||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Phase I Study of Once Every Three Weeks Intravenous Treatment With BI 6727 in Japanese Patients With Advanced Solid Tumours|
|Actual Study Start Date :||April 25, 2011|
|Actual Primary Completion Date :||August 27, 2012|
|Actual Study Completion Date :||May 15, 2014|
Patient to receive low, middle and high doses of Volasertib IV
Drug: Volasertib, low dose, d1q3w
Patient to receive low dose of Volasertib IV
Drug: Volasertib, middle dose, d1q3w
Patient to receive middle dose of Volasertib IV
Drug: Volasertib, high dose, d1q3w
Patient to receive high dose of Volasertib IV
- Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD). [ Time Frame: 21 days ]
The following drug-related adverse events (AE) were defined as DLT;
- Haematological toxicities: CTCAE(Common Terminology Criteria for Adverse Events) grade 4 neutropenia persisted for 7 or more days, CTCAE grade 4 thrombocytopenia or CTCAE grade 3 thrombocytopenia requiring blood transfusion.
- Non-haematological toxicities: CTCAE grade ≥3 non-haematological toxicities. The following toxicity with neutropenia was defined as DLT.- CTCAE grade 3 febrile neutropenia persisted for over 2 days, Clinically significant laboratory abnormalities of CTCAE grade ≥3 persisted for over 3 days. The following laboratory abnormalities should be defined as DLT. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): >5.0 × ULN persisted for 7 days or longer - Creatinine: >3.0 × upper limit of normal(ULN) (if the creatinine abnormality was observed even once) - Persistent electrolyte abnormality assessed by the investigator.
- Maximum Tolerated Dose (MTD) of Volasertib [ Time Frame: 21 days ]Maximum tolerated dose (MTD) of volasertib was the highest dose tested at which DLT was developed in not more than 1 of 6 patients in the course 1.
- Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 [ Time Frame: 6 months ]Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1: Unconfirmed objective response. The patients with complete response (CR) or partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Disease Control Rate According to RECIST v1.1 [ Time Frame: 6 months ]Disease control rate according to RECIST v1.1 - Unconfirmed disease control. The patients with complete response (CR), partial response (PR) or stable disease (SD).
- Cmax of Volasertib (BI 6727) [ Time Frame: Pharmacokinetic (PK) plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1. ]Maximum concentration of an analyte in plasma
- Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) of Volasertib (BI 6727) [ Time Frame: PK plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1. ]Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of Volasertib (BI 6727).
- Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz) of Volasertib (BI 6727) [ Time Frame: PK plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1. ]Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point (AUC0-tz) of Volasertib (BI 6727).
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): NCT01348347
|1230.15.001 National Cancer Center Hospital,|
|Chuo-ku, Tokyo, Japan|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|