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Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer
This study has been completed.

First Received on November 24, 2009.   Last Updated on March 6, 2012   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party): Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01023958
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: BI 6727, IV infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Single Arm Phase II Trial of Intravenous BI 6727 in 2nd Line Treatment of Urothelial Cancer

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Response rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Duration of overall response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • PK of BI 6727 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • AEs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2009
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm
open label
Drug: BI 6727, IV infusion
phase II

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Histologically or cytologically confirmed urothelial cancer of the bladder, ureters or renal pelvis.
  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:

  1. More than one prior regimen of chemotherapy including prior adjuvant therapy
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023958

Locations
United States, California
1230.2.5 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1230.2.10 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
United States, Florida
1230.2.34 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1230.2.29 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
United States, Illinois
1230.2.6 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1230.2.17 Boehringer Ingelheim Investigational Site
Joliet, Illinois, United States
United States, Louisiana
1230.2.24 Boehringer Ingelheim Investigational Site
Metairie, Louisiana, United States
United States, Maryland
1230.2.1 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
United States, Nevada
1230.2.25 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
1230.2.36 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
United States, New Hampshire
1230.2.19 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
United States, New York
1230.2.23 Boehringer Ingelheim Investigational Site
New York, New York, United States
1230.2.20 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, North Carolina
1230.2.12 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
United States, Pennsylvania
1230.2.4 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Texas
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
United States, Virginia
1230.2.44 Boehringer Ingelheim Investigational Site
Fairfax, Virginia, United States
Taiwan
1230.2.51 Boehringer Ingelheim Investigational Site
Tainan, Taiwan
1230.2.50 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01023958     History of Changes
Other Study ID Numbers: 1230.2
Study First Received: November 24, 2009
Last Updated: March 6, 2012
Health Authority: Taiwan: Department of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2012