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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962611
• Other study ID #: 12871
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2009
• Last updated: October 5, 2017
• Start date: November 19, 2009
• Est. completion date: February 23, 2016

Study information

• Verified date: October 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 23, 2016
• Est. primary completion date: February 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

References & Publications (2)

A. Patnaik et al. Supplementary materials /Supplementary methods. Annals of Oncology 2016

Rowe EL. Automated drop volume apparatus for surface tension measurement. J Pharm Sci. 1972 May;61(5):781-2. — View Citation

Outcome

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

External Links

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