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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 6727

Schedule A

Group Type EXPERIMENTAL

BI 6727

Intervention Type DRUG

Dose level 1

Interventions

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BI 6727

Dose level 1

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No