Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00969553
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : March 7, 2012
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: BI 6727 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 6727 Administered Intravenously in Asian Patients With Various Solid Cancers With Repeated Administration in Patients With Clinical Benefit
Study Start Date : August 2009
Actual Primary Completion Date : September 2011

Arm Intervention/treatment
Experimental: BI 6727
Schedule A
Drug: BI 6727
Dose level 1

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Adverse event [ Time Frame: 3 weeks after last administration of BI 6727 ]
  2. Progression-free survival [ Time Frame: about 6 months ]
  3. Response duration [ Time Frame: about 6 months ]
  4. objective response [ Time Frame: Every other course from entry to end-of-treatment ]
  5. pharmacokinetics [ Time Frame: Selected time points during first 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Patients with histologically or cytologically confirmed diagnosis of advanced solid cancer
  2. Age 18 years or older
  3. Written informed consent
  4. Eastern Cooperative Oncology Group (ECOG) performance score 2 or less

Exclusion criteria:

  1. Serious illness or concomitant non-oncological disease.
  2. Pregnancy or breast feeding
  3. Active infectious disease
  4. Absolute neutrophil count less than 1,500/cubic millimeter
  5. Platelet count less than 100,000/cubic millimeter
  6. Bilirubin greater than 1.5 mg/dL (> 26 µmol/L, SI unit equivalent)
  7. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal
  8. Serum creatinine greater than 1.5x ULN.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00969553

1230.16.886002 Boehringer Ingelheim Investigational Site
Tainan, Taiwan
1230.16.886001 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT00969553     History of Changes
Other Study ID Numbers: 1230.16
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012