Clinical Study to Evaluate the Maximum Tolerated Dose of BAY79-4620 Given Every 2 Weeks to Patients With Advanced Solid Tumors

NCT ID: NCT01065623

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-08-31

Brief Summary

Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY79-4620 given every 2 weeks to patients with advanced solid tumors

Conditions

Neoplasms

Study Design

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

Study Groups

Arm 1

Group Type: EXPERIMENTAL

BAY79-4620

Intervention Type: DRUG

1-hour infusion every 14 days. Starting dose will be 0.15 mg/ kg and dose will be escalated dependent on any dose limiting toxicities

Interventions

BAY79-4620

1-hour infusion every 14 days. Starting dose will be 0.15 mg/ kg and dose will be escalated dependent on any dose limiting toxicities

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The informed consent must be signed before any study specific tests or procedures are done
• Male or female patients aged >18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
• Life expectancy of at least 12 weeks
• Patients with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or patients must have actively refused any treatment which would be regarded standard, and/or if in the judgment of the investigator or his designated associate(s), experimental treatment is clinically and ethically acceptable
• Radiographically or clinically evaluable tumor
• Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to start of first dose

Exclusion Criteria

• History of cardiac disease: congestive heart failure (CHF) > NYHA Class II; myocardial infarction within 3 months prior to study entry; new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
• Uncontrolled hypertension defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg, despite optimal medical management
• Symptomatic metastatic brain or meningeal tumors unless the patient is >6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
• Patients with severe renal impairment or on dialysis
• Known human immunodeficiency virus (HIV) infection or patients with an active hepatitis B or C infection necessitating treatment. Patients with chronic hepatitis B or C are eligible
• Active clinically serious infections of Common Terminology Criteria for Adverse Events Version 3 (CTCAE v3.0) > Grade 2
• Serious, non-healing wound, ulcer, or bone fracture
• Major surgery, open biopsy, or significant trauma within 4 weeks prior to the first dose of study drug
• Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks of start of first dose
• Radiotherapy to the target lesions within 3 weeks prior to Cycle 1 Day 1 (first dose of study drug). Palliative radiotherapy will be allowed as described in the study protocol. Radiotherapy to the target lesions during study will be regarded as progressive disease

• Minimum Eligible Age: 18 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

Rotterdam, , Netherlands

Utrecht, , Netherlands

Countries

Netherlands

Other Identifiers

2009-015085-58

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12672

Identifier Type: -

Identifier Source: org_study_id