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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

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

Inclusion 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 ┬Ámol/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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

3 weeks

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Taiwan: Department of Health

Study ID:

1230.16

NCT ID:

NCT00969553

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Neoplasms
  • Neoplasms

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