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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00969553
First received: August 31, 2009
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Neoplasms
 Drug: BI 6727
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event [ Time Frame: 3 weeks after last administration of BI 6727 ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
  • Response duration [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
  • objective response [ Time Frame: Every other course from entry to end-of-treatment ] [ Designated as safety issue: No ]
  • pharmacokinetics [ Time Frame: Selected time points during first 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: August 2009
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 6727
Schedule A
 Drug: BI 6727
Dose level 1

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969553

Locations
Taiwan
1230.16.886002 Boehringer Ingelheim Investigational Site
Tainan, Taiwan
1230.16.886001 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: NCT00969553     History of Changes
Other Study ID Numbers: 1230.16
Study First Received: August 31, 2009
Last Updated: March 6, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013