Japanese BAY86-9766 Monotherapy Phase I Study

Neoplasms Clinical Trial

Official title:

Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179295
• Other study ID #: 15091
• Status: Completed
• Phase: Phase 1
• First received: August 10, 2010
• Last updated: June 19, 2017
• Start date: November 19, 2010
• Est. completion date: April 27, 2012

Study information

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

Clinical Trial Summary

This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 27, 2012
• Est. primary completion date: April 27, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Japanese patients, who are at least 18 years of age at the first screening examination/ visit, with advanced or refractory solid tumors not amenable to standard therapy.

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

• At least one measurable lesion or evaluable disease according to response evaluation criteria in solid tumors (RECIST) version 1.1

• Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1

• Life expectancy of at least 12 weeks

Exclusion Criteria:

• Use of any anti-cancer therapy including chemotherapy, investigational agents or devices and immunotherapy within 4 weeks of the first dose of study medication

• Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management

• Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C

• Inadequate bone marrow, liver and renal function

• Inability to swallow oral medications or any condition that could affect the absorption of orally administered drugs

• Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and CYP2C19 inhibitors/ inducers

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• BAY86-9766
BAY86-9766 30 mg twice a day (bid).
• BAY86-9766
BAY86-9766 50 mg twice a day (bid).
• BAY86-9766
BAY86-9766 100 mg once a day (od)
• BAY86-9766
BAY86-9766 60 mg once a day (od)

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	Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.		At the end of 30-day follow up after discontinuation of study drug administration
Primary	Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17).		Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.
Secondary	Response rate		On average 3 months
Secondary	Disease control rate		On average 3 months

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