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

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

Official Title
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An Open Label Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Maximum Tolerated Dose and Biomarker Response After Intravenous Administration of Weekly BAY80-6946 to Patients With Advanced Cancer

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: Copanlisib (Aliqopa, BAY80-6946)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Copanlisib<br> | Drug: Copanlisib (Aliqopa, BAY80-6946)<br>* BAY80-6946 given IV over 1 hour every week for three weeks with a one week break until progression or unacceptable toxicities develop.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize safety, tolerability + pharmacokinetics, to determine the maximum tolerated dose of BAY80-6946 administered 1x weekly for 3 weeks, every 4weeks, as a 1h-intravenous infusion. Evaluate biomarkers that may be predictive of tumor response. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effects of BAY80-6946 on blood glucose and insulin, and its safety in patients with type I or II diabetes. |  | 2 years | 
| Evaluate for early signs of efficacy in expansion cohorts |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumors, Advanced cancer