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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00962611
First received: August 19, 2009
Last updated: March 19, 2014
Last verified: March 2014

August 19, 2009
March 19, 2014
November 2009
January 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Characterize safety, tolerability and pharmacokinetics, to determine the maximum tolerated dose of BAY80-6946 administered once weekly for 3 weeks, every four weeks, as one hour intravenous infusion, to patients with advanced cancer. Evaluate biomarkers. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00962611 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Evaluate for early signs of efficacy in expansion cohorts [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Evaluate for early signs of efficacy in expansion cohorts. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: Copanlisib (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.
Experimental: Copanlisib
Intervention: Drug: Copanlisib (BAY80-6946)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
57
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00962611
12871
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP