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

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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

BI 6727

Experimental group

Description:

Schedule A

Treatment:

Drug: BI 6727