Open Label Study of BAY1082439 in Patients With Advanced Cancer

NCT01728311 | Completed Phase 1

• 1 other identifier: 15734
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 5

Brief Summary

The purpose of this study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events as a measure of safety and tolerability

  Up to 2 years

• Maximum tolerated dose of BAY1082439

  Up to 1 year

• Maximum observed plasma concentration (Cmax) of BAY1082439 after a single dose

  Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2

• Time to Cmax (tmax) of BAY1082439 after a single dose

  Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2

• Area under the plasma concentration-time curve (AUC[0-t]) of BAY1082439 after a single dose

  Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2

Secondary Outcomes (5)

• Area under the concentration-time curve over the dosing interval (AUC[0-tau])

  PK parameters following single and repeat-dose administration in cycle 1

• Maximum observed concentration (Cmax)

  PK parameters following single and repeat-dose administration in cycle 1

• Time of occurrence of Cmax (tmax)

  PK parameters following single and repeat-dose administration in cycle 1

• Terminal phase half-life (t1/2)

  PK parameters following single and repeat-dose administration in cycle 1

• Tumor response based on Response Evaluation Criteria in Solid Tumors, Version 1.1

  Up to 2 years

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: BAY1082439

Interventions

BAY1082439 DRUG

BAY1082439 will be given orally once daily with a 21 days cycle. Dose will be started from 15mg.

Arm 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
• Expansion phase only: Subjects with histologically or cytologically confirmed, locally advanced or metastatic endometrial cancer or breast cancer or iNHL, who are refractory to or have exhausted all available therapies
• International normalized ratio (INR) and partial thromboplastin time (PTT) \<1.5 x ULN \[Subjects on anticoagulation with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.\] For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care
• Measurable or evaluable disease
• Life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Adequate bone marrow, liver and renal function

You may not qualify if:

• History of cardiac disease: congestive heart failure \> New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months prior to the first dose of study drug), myocardial infarction within the past 6 months prior to the first dose of study drug, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
• History of diabetes mellitus or gestational diabetes mellitus
• Fasting blood glucose level \>125 mg/dL or HbA1c 7% at screening
• Active clinically serious infections \> Grade 2
• History of organ allograft
• Seizure disorder requiring therapy (such as steroids or anti-epileptics)

Sponsors & Collaborators

• Bayer: lead

Study Sites (5)

Unknown Facility

Singapore, 119228, Singapore

Location

Unknown Facility

Singapore, 169610, Singapore

Location

Unknown Facility

Seoul, 03080, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 19, 2012
• Study Start: November 21, 2012
• Primary Completion: June 3, 2016
• Study Completion: February 6, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

TW (1); KR (2); SG (2)