Phase 1
Completed N=30
Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors
Neoplasms
Source: ClinicalTrials.gov NCT01022853 ↗
Enrolled (actual)
30
Serious AEs
26.7%
Results posted
Jul 2018
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD). — 0; 0; 3; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD). |
0; 0; 3; 2; 2 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Volasertib in Combination With Nintedanib |
300 | — |
| SECONDARY Number of Participants With Drug Related Adverse Events |
3; 3; 12; 7; 2 | — |
| SECONDARY Number of Participants With Dose Limiting Toxicities |
0; 1; 6; 2; 2 | — |
| SECONDARY Cmax of Volasertib |
164; 409; 532; 534; 1210 | — |
| SECONDARY CL of Volasertib |
720; 685; 792; 849; 589 | — |
| SECONDARY Vss of Volasertib |
5710; 5590; 5010; 6080; 2710 | — |
| SECONDARY Cmax of Nintedanib |
22.5; 30.2; 36.7; 34.2 | — |
| SECONDARY AUC(0-6h) of Nintedanib |
69.5; 104.0; 135.0; 121.0 | — |
| SECONDARY Tmax of Nintedanib |
3.00; 1.88; 2.42; 2.00 | — |
| SECONDARY Number of Patients With Best Overall Response |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Patients With Objective Response (OR) |
0; 0; 2; 0; 0; 0 | — |
| SECONDARY Number of Patients With Disease Control |
2; 2; 9; 4; 1 | — |
| SECONDARY Duration of Disease Control |
163.0; 348.0; 141.0; 215.0; 56.0; 161.5 | — |
| SECONDARY Progression Free Survival (PFS) |
114.0; 116.0; 99.0; 72.5; 83.0; 96.5 | — |
Eligibility Criteria
Inclusion criteria
- Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, and for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
- Age > or = 18 years
- European Cooperative Oncology Group performance status upper limit of normal (ULN)
- Alaninaminotransferase (ALT) and/or Aspartateaminotransferase (AST) >= 1.5 x ULN (in case of liver metastases: ALT and AST >= 2.5 x ULN)
- Serum creatinine > 1.5 mg/dl
- Major injuries and/or surgery or bone fracture within 28 days before first administration of trial drug (BIBF 1120), or planned surgical procedures during the trial period
- Known history of clinically relevant QT prolongation (e.g. long QT syndrome)
- History of severe haemorrhagic or thromboembolic event in the past 6 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis)
- Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid < or = 325mg per day)
- Active alcohol or drug abuse
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception during the trial
- Pregnancy or breast-feeding
- Patients unable to comply with the protocol
- Uncontrolled hypertension
Data sourced from ClinicalTrials.gov (NCT01022853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.