Japanese BAY80-6946 Monotherapy Phase I Study

NCT ID: NCT01404390

Last Updated: 2017-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-18
• Study Completion Date: 2012-07-12

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

BAY80-6946

Intervention Type: DRUG

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

Arm 2

Group Type: EXPERIMENTAL

BAY80-6946

Intervention Type: DRUG

0.8mg/ kg, iv, day 1,8 and 15, every 28 days

Interventions

BAY80-6946

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

Intervention Type: DRUG

BAY80-6946

0.8mg/ kg, iv, day 1,8 and 15, every 28 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Kashiwa, Chiba, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 27915408 (View on PubMed)

Other Identifiers

15205

Identifier Type: -

Identifier Source: org_study_id