Monotherapy Dose Finding With BI 847325 in Solid Tumours

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: day 1 to day 14; Drug: day 1 to day 5

• Registration Number: NCT01324830
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of the Phase Ia (dose escalation) part of this trial is to assess the maximum tolerated dose (MTD) of BI 847325 administered at escalating doses in 2 treatment arms. In the Phase Ib expansion part of the trial, the aim is to further evaluate the safety profile of BI 847325 at the recommended dose and schedule and to assess target modulation and the potential antitumour efficacy in patients with selected tumour types.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Study Start: 2011-04-15
• Primary Completion: 2013-06-06
• Study Completion: 2013-10-10
• Status Verified: 2018-06
• Results First Submitted: 2018-06-07
• Results First Submitted QC: 2018-06-07
• Last Update Submitted: 2018-06-07
• Results First Posted: 2018-12-21
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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
arm A	day 1 to day 14	14 days once a day oral intake of BI 847325 followed by 7 days break in 3-week cycles
arm B	day 1 to day 5	5 days once daily oral intake of BI 847325 followed by 2 days break, repeated every week

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Dose Limiting Toxicity During the First Treatment Cycle in Phase Ia Part of the Study	3 weeks	Occurrence of dose limiting toxicity (DLT) during the first treatment cycle for the treatment Schedules A and B.; Some patients excluded from Treated Set (TS) as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients.

Secondary Outcome Measures

Name	Time	Method
Best Overall Response	From the start of treatment until the last evaluable assessment. The data cut-off date is 29-Nov-2013	Best overall response was the best response a patient experienced during their time on study from the start of treatment until: disease progression, the last evaluable assessment in the absence of progression, or the start of subsequent anti-cancer therapy. Death was not considered as progressive disease when determining best overall response; patients who died prior to an evaluable imaging assessment were reported as not evaluable. Some patients were excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients.
Objective Response	From the start of treatment and the earliest of disease progression, death, or the end of treatment. The data cut-off date is 29-Nov-2013.	Objective response was a best overall response of complete or partial response, recorded between the start of treatment and the earliest of disease progression, death, or the end of treatment.; Some patients excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients.
Disease Control	From the start of treatment to the earliest of disease progression, death, or the end of treatment. The data cut-off date is 29-Nov-2013.	Disease control was a best overall response of complete response, partial response or stable disease, recorded between the start of treatment and the earliest of disease progression, death, or the end of treatment. Some patients excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients.

Trial Locations

Locations (2)

1287.1.3201 Boehringer Ingelheim Investigational Site; 🇧🇪 Bruxelles, Belgium

1287.1.3202 Boehringer Ingelheim Investigational Site; 🇧🇪 Leuven, Belgium