Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer
NCT ID: NCT01023958
Last Updated: 2017-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2009-11-19
2011-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single arm
open label
BI 6727, IV infusion
phase II
Interventions
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BI 6727, IV infusion
phase II
Eligibility Criteria
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Inclusion Criteria
2. Patients with stage III, IV or recurrent urothelial cancer of the bladder, ureter or renal pelvis after failure or recurrence after first line or adjuvant/neoadjuvant chemotherapy. Recurrence is defined as relapse within 2 years after cessation of prior first-line chemotherapy.
3. Male or female patient aged 18 years or older
4. Life expectancy of at least three (3) months
5. Eastern Co-operative Oncology Group performance score of 2 or less
6. At least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT
7. The patient must have given written informed consent prior to inclusion into the trial which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation
Exclusion Criteria
2. Brain metastases
3. Patients with bone metastasis as the only site of disease are excluded
4. Serious illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety, interfere with the evaluation of the safety of the test drug or limit compliance with trial requirements.
5. QTc prolongation deemed clinically relevant by the investigator
6. Second malignancy currently requiring active therapy
7. Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
8. Absolute neutrophil count (ANC) \<1,500/µl
9. Platelet count \<100,000/µl
10. Hemoglobin \<9 g/dl
11. Total bilirubin \>1.5 mg/dl
12. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \>2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \>5 x ULN in case of known liver metastases
13. Serum creatinine \>1.5 x ULN
14. Chemo-, Radio- or immunotherapy within the past 4 weeks. This does not apply to steroids and bisphosphonates.
15. Active infectious disease, or HIV, Hepatitis-B or -C infection
16. Active drug or alcohol abuse
17. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial
18. Pregnancy or breast feeding
19. Treatment with any investigational drug within the past 4 weeks or within less than four half-life times of the investigational drug before treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant.
20. Prior treatment with Polo-like kinase 1 (Plk1) inhibitor
21. Patient unable to comply with the protocol
22. Any known hypersensitivity to the trial drugs or their excipients
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1230.2.5 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1230.2.10 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1230.2.34 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1230.2.29 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1230.2.6 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1230.2.17 Boehringer Ingelheim Investigational Site
Joliet, Illinois, United States
1230.2.24 Boehringer Ingelheim Investigational Site
Metairie, Louisiana, United States
1230.2.1 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
1230.2.25 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
1230.2.36 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
1230.2.19 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
1230.2.20 Boehringer Ingelheim Investigational Site
New York, New York, United States
1230.2.23 Boehringer Ingelheim Investigational Site
New York, New York, United States
1230.2.12 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1230.2.4 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1230.2.38 Boehringer Ingelheim Investigational Site
Beaumont, Texas, United States
1230.2.41 Boehringer Ingelheim Investigational Site
Tyler, Texas, United States
1230.2.43 Boehringer Ingelheim Investigational Site
Webster, Texas, United States
1230.2.44 Boehringer Ingelheim Investigational Site
Fairfax, Virginia, United States
1230.2.51 Boehringer Ingelheim Investigational Site
Tainan City, , Taiwan
1230.2.50 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
Countries
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References
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Stadler WM, Vaughn DJ, Sonpavde G, Vogelzang NJ, Tagawa ST, Petrylak DP, Rosen P, Lin CC, Mahoney J, Modi S, Lee P, Ernstoff MS, Su WC, Spira A, Pilz K, Vinisko R, Schloss C, Fritsch H, Zhao C, Carducci MA. An open-label, single-arm, phase 2 trial of the Polo-like kinase inhibitor volasertib (BI 6727) in patients with locally advanced or metastatic urothelial cancer. Cancer. 2014 Apr 1;120(7):976-82. doi: 10.1002/cncr.28519. Epub 2013 Dec 11.
Other Identifiers
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1230.2
Identifier Type: -
Identifier Source: org_study_id