BI 6727 (Volasertib) Monotherapy Phase I Trial in Japanese Patients With Advanced Solid Tumours

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Volasertib, low dose, d1q3w; Drug: Volasertib, middle dose, d1q3w; Drug: Volasertib, high dose, d1q3w

• Registration Number: NCT01348347
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This open-label phase I dose escalation trial, 1230.15, is the first trial with Volasertib in Japanese advanced cancer patients. The trial will investigate the maximum tolerated dose (MTD), safety, tolerability, and preliminary efficacy of this specific polo-like kinase 1 (Plk1) inhibitor in advanced cancer patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-25
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Primary Completion: 2012-08-27
• Study Completion: 2014-05-15
• Results First Submitted: 2017-10-23
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-03
• Last Update Submitted: 2018-08-03
• Results First Posted: 2018-08-06
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volasertib	Volasertib, middle dose, d1q3w	Patient to receive low, middle and high doses of Volasertib IV
Volasertib	Volasertib, high dose, d1q3w	Patient to receive low, middle and high doses of Volasertib IV
Volasertib	Volasertib, low dose, d1q3w	Patient to receive low, middle and high doses of Volasertib IV

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of Volasertib	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.
Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).	21 days	The following drug-related adverse events (AE) were defined as DLT; 1. 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.; 2. 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.

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate According to RECIST v1.1	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).
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1	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.
Cmax of Volasertib (BI 6727)	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)	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)	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).

Trial Locations

Locations (1)

1230.15.001 National Cancer Center Hospital,; 🇯🇵 Chuo-ku, Tokyo, Japan