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

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Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Neoplasms

Treatments

Drug: BI 6727

Study type

Interventional

Funder types

Industry

Identifiers

NCT00969553
1230.16

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

59 participants in 1 patient group

BI 6727
Experimental group
Description:
Schedule A
Treatment:
Drug: BI 6727

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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