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An Open Label, Single Centre, Phase I Study of PI3K Inhibitor BAY80-6946 to Evaluate the Safety, Tolerability and Pharmacokinetics in Japanese Patients With Advanced or Refractory Solid Tumours


Phase 1
20 Years
80 Years
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

An Open Label, Single Centre, Phase I Study of PI3K Inhibitor BAY80-6946 to Evaluate the Safety, Tolerability and Pharmacokinetics in Japanese Patients With Advanced or Refractory Solid Tumours


Inclusion Criteria:



- Cancer patients

- Japanese patients, who are at least 20 years of age

- Histological or cytological documentation of non-hematologic, malignant solid
tumours, excluding primary brain or spinal tumours, with no past or current
involvement in the central nervous system (CNS)

- At least one measurable lesion or evaluable disease according to RECIST (version 1.1)

- Eastern Cooperative Oncology performance status (ECOG-PS) of 0 or 1

- Life expectancy of at least 12 weeks

- Advanced or refractory solid tumours not amenable to standard therapy, at the first
screening examination/visit

Exclusion Criteria:

- Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of first
study treatment. Patients must have recovered from the toxic effects of the previous
anti-cancer chemotherapy or immunotherapy by the investigator (with the exception of
alopecia).

- Radiotherapy to target lesions during study or within 4 weeks of first study
treatment

- Investigational drug therapy outside of this trial during or within 4 weeks of first
study treatment

- Current diagnosis of Type I or II diabetes mellitus or fasting blood glucose level
>125 mg/dL at screening, and/or HbA1c>/= 6.5%

- Past and current histories of cardiac disease congestive heart failure > New York
Heart Association (NYHA) Class II; active coronary artery disease, myocardial
infarction within 6 months prior to study entry; new onset of angina within 3 months
prior to study entry or unstable angina or ventricular cardiac arrhythmias requiring
anti-arrhythmic therapy

- Active and clinically serious infections >Grade 2 (National Cancer Institute Common
Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03)

- Uncontrolled hypertension defined as systolic blood pressure >150 mm Hg or diastolic
pressure > 90 mm Hg, despite optimal medical management

- Patients undergoing renal dialysis

- Pregnant or breast feeding women

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of subjects with adverse events by the administration of BAY80-6946

Outcome Time Frame:

In Cycle 1 which consists of 28 days.

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

15205

NCT ID:

NCT01404390

Start Date:

August 2011

Completion Date:

July 2012

Related Keywords:

  • Neoplasms
  • Phase I
  • Japanese
  • Neoplasms

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