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Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer
Phase 2 trial testing BI 6727, IV infusion in Neoplasms in 50 participants. Completed in 19 September 2011.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 19 November 2009 |
| Primary completion | 19 September 2011 |
| Estimated completion | 19 September 2011 |
| Sites | 21 locations across Taiwan, United States |
Boehringer Ingelheim — full company profile →
18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 14.0 | 5.8 – 26.7 |
Progression-free survival (PFS) is the time from first treatment to the occurrence of tumor progression or death, whichever occurs first. Disease progression is defined according to the RECIST guideline but also includes the investigators' assessment which may, in some cases, include only clinical progression (deterioration of general health status per investigator). PFS was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals. Patients without evidence of disease progression were to be censored at the last image date.
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 6.1 | 5.6 – 11.1 |
Overall survival (OS) is the time from first infusion to death. Patients who were alive at the time of analysis or lost to follow-up were censored at the last follow-up date when they were known to be alive. Overall survival was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 8.5 | 3.9 – 12.1 |
The duration of overall response is measured from the time of first response (CR or PR) to progression or death whichever occurs first.
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 41.0 | 29.1 – 77.3 |
Disease control rate. Disease control is defined as having a best overall response of complete response (CR), partial response (PR) or stable disease (SD).
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 40.0 | 26.4 – 54.8 |
Disease control is defined as having a best overall response of CR, PR, or SD. The duration of disease control is measured from the time of first response to progression or death whichever occurs first.
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 27.0 | 10.1 – 77.3 |
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of volasertib
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 5470 | ± 30.6 |
Maximum measured concentration in plasma (Cmax) of volasertib
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 253 | ± 51.9 |
Terminal half-life (t1/2) of volasertib
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 150 | ± 17.0 |
Total plasma clearance after intravascular administration (CL) of volasertib
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 914 | ± 30.6 |
Apparent volume of distribution at steady state following intravascular administration (Vss) of volasertib
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 7470 | ± 32.4 |
Time from dosing to maximum measured concentration (Tmax) of volasertib
| Group | Value | 95% CI |
|---|---|---|
| Volasertib (BI 6727) | 2.03 | 1.53 – 4.17 |
Time frame: From first drug administration until end of study, up to 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Volasertib (BI 6727) |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Renal failure acute | Renal and urinary disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Pericardial effusion | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Pyrexia | General disorders | — |
| Bacteraemia | Infections and infestations | — |
| Gastroenteritis | Infections and infestations | — |
| Infection | Infections and infestations | — |
| Perirectal abscess | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Septic shock | Infections and infestations | — |
| Urosepsis | Infections and infestations | — |
| Foreign body | Injury, poisoning and procedural complications | — |
| Urostomy complication | Injury, poisoning and procedural complications | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — |
| Reaction | System | Volasertib (BI 6727) |
|---|---|---|
| Fatigue | General disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Anxiety | Psychiatric disorders | — |
| Insomnia | Psychiatric disorders | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Asthenia | General disorders | — |
| Pyrexia | General disorders | — |
| Oedema peripheral | General disorders | — |
| Weight decreased | Investigations | — |
| Groin pain | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Depression | Psychiatric disorders | — |
| Dysuria | Renal and urinary disorders | — |
| Pollakiuria | Renal and urinary disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Abdominal pain lower | Gastrointestinal disorders | — |
| Chest pain | General disorders | — |
| Chills | General disorders | — |
| Pain | General disorders | — |
| Oral candidiasis | Infections and infestations | — |
| Blood creatinine increased | Investigations | — |
| Hypercalcaemia | Metabolism and nutrition disorders | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Renal failure | Renal and urinary disorders | — |
Most-reported serious reactions: Anaemia, Urinary tract infection, Decreased appetite, Dehydration, Hyponatraemia, Transitional cell carcinoma, Renal failure acute, Febrile neutropenia.
Data from ClinicalTrials.gov NCT01023958 adverse events section.
The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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