BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer

Bayer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Copanlisib (Aliqopa, BAY80-6946)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00962611

12871

Details and patient eligibility

About

The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >/= 18 years.
• Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, or history of central nervous system metastases
• At least one measurable lesion or evaluable disease
• Life expectancy of at least 12 weeks
• ECOG Performance Status of 0, 1 or 2
• PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated 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]. Low-dose aspirin is permitted (</= 100 mg daily).
• Adequate bone marrow, liver and renal function
• Ability to understand and to sign an informed consent form; a signed informed consent must be obtained prior to any study specific procedures

Exclusion criteria

• History of cardiac disease congestive heart failure (CHF) > NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or Digoxin are permitted).
• Current diagnosis of type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, or HbA1c 7%
• Active clinically serious infections > Grade 2 (NCI-CTCAE Version 3.0)
• History of having received allogeneic organ transplant
• Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed throughout the entire study.
• Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Copanlisib

Experimental group

Treatment:

Drug: Copanlisib (Aliqopa, BAY80-6946)