Japanese BAY80-6946 Monotherapy Phase I Study

NCT01404390 | Completed Phase 1

• 1 other identifier: 15205
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms

Keywords

Phase I; Japanese

Outcome Measures

Primary Outcomes (10)

• Number of subjects with adverse events

  169 days

• 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

• 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

• 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

• 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

• 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

• 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

• AUC(0-25) divided by dose (mg) (AUC(0-25)/D)

  0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15

• AUC from time 0 to last data point (AUC(0-tlast))

  0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15

• 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 Outcomes (13)

• Area under the plasma concentration-time curve of (AUC) of BAY80-6946

  0 - 168 hours in Cycle1 Day1

• Half-life associated with terminal slope of drug in plasma (t1/2)

  0 - 168 hours in Cycle1 Day1

• Mean residence time of drug in plasma (MRT)

  0 - 168 hours in Cycle1 Day1

• Total body clearance of drug from plasma (CL)

  0 - 168 hours in Cycle1 Day1

• Volume of drug distribution during terminal phase after single dose administration (Vz)

  0 - 168 hours in Cycle1 Day1

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: BAY80-6946

Arm 2

EXPERIMENTAL

Drug: BAY80-6946

Interventions

BAY80-6946 DRUG

0.4mg/ kg, iv, day 1,8 and 15, every 28 days

Arm 1

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Kashiwa, Chiba, 277-8577, Japan

Location

Related Publications (1)

• Doi T, Fuse N, Yoshino T, Kojima T, Bando H, Miyamoto H, Kaneko M, Osada M, Ohtsu A. A Phase I study of intravenous PI3K inhibitor copanlisib in Japanese patients with advanced or refractory solid tumors. Cancer Chemother Pharmacol. 2017 Jan;79(1):89-98. doi: 10.1007/s00280-016-3198-0. Epub 2016 Dec 3.

  PMID: 27915408 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 28, 2011
• Study Start: August 18, 2011
• Primary Completion: March 22, 2012
• Study Completion: July 12, 2012
• Last Updated: December 14, 2017

Record last verified: 2017-12

Locations

JP (1)