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An Open Label Phase I Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY79-4620 Administered as an Intravenous Infusion Once Every 2 Weeks in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

An Open Label Phase I Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY79-4620 Administered as an Intravenous Infusion Once Every 2 Weeks in Patients With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Event reporting

Outcome Time Frame:

Approximately 3 years after initiation of the trial

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

12672

NCT ID:

NCT01065623

Start Date:

April 2010

Completion Date:

August 2010

Related Keywords:

  • Neoplasms
  • Phase I
  • Dose escalation
  • Immunoconjugate
  • Neoplasms

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