Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer

NCT01023958 | Completed Phase 2 Results

• 1 other identifier: 1230.2
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 21

Brief Summary

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective Tumour Response According to RECIST Criteria

  Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

  From first drug administration until end of study, up to 2 years

Secondary Outcomes (23)

• Progression-free Survival

  Time from first treatment to the occurrence of tumor progression or death, up to 2 years

• Overall Survival

  Time from first infusion to death, up to 2 years

• Duration of Overall Response

  From the time of first response (CR or PR) to progression or death, up to 2 years

• Disease Control Rate

  From first drug administration until end of study, up to 2 years

• Duration of Disease Control

  Time of first response to progression or death, up to 2 years

Study Arms (1)

single arm

EXPERIMENTAL

open label

Drug: BI 6727, IV infusion

Interventions

BI 6727, IV infusion DRUG

phase II

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed urothelial cancer of the bladder, ureters or renal pelvis.
• 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.
• Male or female patient aged 18 years or older
• Life expectancy of at least three (3) months
• Eastern Co-operative Oncology Group performance score of 2 or less
• 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

You may not qualify if:

• More than one prior regimen of chemotherapy including prior adjuvant therapy
• Brain metastases
• Patients with bone metastasis as the only site of disease are excluded
• 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.
• QTc prolongation deemed clinically relevant by the investigator
• Second malignancy currently requiring active therapy
• Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
• Absolute neutrophil count (ANC) \<1,500/µl
• Platelet count \<100,000/µl
• Hemoglobin \<9 g/dl
• Total bilirubin \>1.5 mg/dl
• 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
• Serum creatinine \>1.5 x ULN
• Chemo-, Radio- or immunotherapy within the past 4 weeks. This does not apply to steroids and bisphosphonates.
• Active infectious disease, or HIV, Hepatitis-B or -C infection

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (21)

1230.2.5 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Location

1230.2.10 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1230.2.34 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1230.2.29 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1230.2.6 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1230.2.17 Boehringer Ingelheim Investigational Site

Joliet, Illinois, United States

Location

1230.2.24 Boehringer Ingelheim Investigational Site

Metairie, Louisiana, United States

Location

1230.2.1 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1230.2.25 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1230.2.36 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1230.2.19 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Location

1230.2.20 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1230.2.23 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1230.2.12 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1230.2.4 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1230.2.38 Boehringer Ingelheim Investigational Site

Beaumont, Texas, United States

Location

1230.2.41 Boehringer Ingelheim Investigational Site

Tyler, Texas, United States

Location

1230.2.43 Boehringer Ingelheim Investigational Site

Webster, Texas, United States

Location

1230.2.44 Boehringer Ingelheim Investigational Site

Fairfax, Virginia, United States

Location

1230.2.51 Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

1230.2.50 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 24339028 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

BI 6727; Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: December 2, 2009
• Study Start: November 19, 2009
• Primary Completion: September 19, 2011
• Study Completion: September 19, 2011
• Last Updated: November 22, 2017
• Results First Posted: November 22, 2017

Record last verified: 2017-10

Locations

TW (2); US (19)