An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 in Combination With Oral BIBF 1120 in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
Overview
- Phase
- Phase 1
- Intervention
- BI 6727
- Conditions
- Neoplasms
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD).
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in patients with advanced or metastatic solid tumours.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BIBF 1120 and BI 6727
Finding Maximum Tolerated Dose of BI 6727 in combination with BIBF 1120
Intervention: BI 6727
BIBF 1120 and BI 6727
Finding Maximum Tolerated Dose of BI 6727 in combination with BIBF 1120
Intervention: BIBF 1120
Outcomes
Primary Outcomes
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD).
Time Frame: 28 days
DLT was defined as: 1. Drug-related CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or 2. Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or 3. CTCAE grade 4 thrombocytopenia
Maximum Tolerated Dose (MTD) of Volasertib in Combination With Nintedanib
Time Frame: 28 days
The MTD was determined using a 3+3 design with de-escalation. The MTD was defined as the highest dose level at which maximal 1 out of 6 patients experienced DLT in the first course of the escalation nd de-escalation phase. However, all DLT's occurring in the trial were considered for selection of the recommended dose for further development.
Secondary Outcomes
- Number of Participants With Drug Related Adverse Events(From first study drug administration until 28 days after the last administration of any study medication, up to 485 days)
- Number of Participants With Dose Limiting Toxicities(From first study drug administration until 28 days after the last administration of any study medication, up to 485 days)
- Cmax of Volasertib(0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion)
- CL of Volasertib(0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion)
- Vss of Volasertib(0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion)
- Cmax of Nintedanib(5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9)
- AUC(0-6h) of Nintedanib(5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9)
- Tmax of Nintedanib(5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9)
- Number of Patients With Best Overall Response(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)
- Number of Patients With Objective Response (OR)(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)
- Number of Patients With Disease Control(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)
- Duration of Disease Control(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)
- Progression Free Survival (PFS)(Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.)