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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00962611
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : October 6, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Copanlisib (Aliqopa, BAY80-6946) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 19, 2009
Actual Primary Completion Date : February 23, 2016
Actual Study Completion Date : February 23, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Copanlisib

Arm Intervention/treatment
Experimental: Copanlisib Drug: Copanlisib (Aliqopa, BAY80-6946)
BAY80-6946 given IV over 1 hour every week for three weeks with a one week break until progression or unacceptable toxicities develop.

Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00962611

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United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
San Antonio, Texas, United States, 78229-3307
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Publications of Results:
Other Publications:
A. Patnaik et al. Supplementary materials /Supplementary methods. Annals of Oncology 2016

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT00962611    
Other Study ID Numbers: 12871
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Keywords provided by Bayer:
Solid tumors
Advanced cancer