Japanese BAY80-6946 Monotherapy Phase I Study

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404390
• Other study ID #: 15205
• Status: Completed
• Phase: Phase 1
• First received: July 27, 2011
• Last updated: December 13, 2017
• Start date: August 18, 2011
• Est. completion date: July 12, 2012

Study information

• Verified date: December 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted as an open label, single centre, Phase I study of PI3K (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8 and Day 15 with three weeks on and one week off in each treatment cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 12, 2012
• Est. primary completion date: March 22, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• BAY80-6946
0.4mg/ kg, iv, day 1,8 and 15, every 28 days
• BAY80-6946
0.8mg/ kg, iv, day 1,8 and 15, every 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		169 days
Primary	Maximum drug concentration in plasma after single dose administration (Cmax)		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
Primary	Cmax divided by dose (mg) per kg body weight (Cmax,norm)		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
Primary	Cmax divided by dose (mg) (Cmax/D)		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
Primary	Area under the concentration-time curve time 0 to 8 hours (AUC(0-8))		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
Primary	Area under the concentration-time curve from time 0 to 25 hours (AUC(0-25))		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
Primary	AUC(0-25) divided by dose (mg) per kg body weight (AUC(0-25)norm)		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
Primary	AUC(0-25) divided by dose (mg) (AUC(0-25)/D)		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
Primary	AUC from time 0 to last data point (AUC(0-tlast))		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
Primary	Time to maximum drug concentration in plasma (tmax)		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day 15
Secondary	Area under the plasma concentration-time curve of (AUC) of BAY80-6946		0 - 168 hours in Cycle1 Day1
Secondary	Half-life associated with terminal slope of drug in plasma (t1/2)		0 - 168 hours in Cycle1 Day1
Secondary	Mean residence time of drug in plasma (MRT)		0 - 168 hours in Cycle1 Day1
Secondary	Total body clearance of drug from plasma (CL)		0 - 168 hours in Cycle1 Day1
Secondary	Volume of drug distribution during terminal phase after single dose administration (Vz)		0 - 168 hours in Cycle1 Day1
Secondary	Volume of drug distribution during steady state after single dose administration (Vss)		0 - 168 hours in Cycle1 Day1
Secondary	Accumulation ratio calculated from AUC(0-8) after multiple dosing and AUC(0-8) after single dosing (RAAUC(0-8))		0 - 8 hours in Cycle3 Day15
Secondary	Accumulation ratio calculated from AUC(0-25) after multiple dosing and AUC(0-25) after single dosing (RAAUC(0-25))		0 - 25 hours in Cycle1 Day15
Secondary	Accumulation ration calculated from Cmax after multiple dosing and Cmax after single dosing (RACmax)		0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
Secondary	Overall tumor response rate	Proportion of subjects with confirmed complete and partial response	176 days
Secondary	Overall disease control rate	Proportion of subjects who had a best response rating of complete response, partial response or stable disease	176 days
Secondary	Time to progression of cancer growth		176 days
Secondary	Progression-free survival time		176 days

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