BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer
NCT ID: NCT00962611
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2009-11-19
2016-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Copanlisib
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Scottsdale, Arizona, United States
Pittsburgh, Pennsylvania, United States
San Antonio, Texas, United States
Countries
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References
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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. doi: 10.1002/jps.2600610523. No abstract available.
Patnaik A, Appleman LJ, Tolcher AW, Papadopoulos KP, Beeram M, Rasco DW, Weiss GJ, Sachdev JC, Chadha M, Fulk M, Ejadi S, Mountz JM, Lotze MT, Toledo FG, Chu E, Jeffers M, Pena C, Xia C, Reif S, Genvresse I, Ramanathan RK. First-in-human phase I study of copanlisib (BAY 80-6946), an intravenous pan-class I phosphatidylinositol 3-kinase inhibitor, in patients with advanced solid tumors and non-Hodgkin's lymphomas. Ann Oncol. 2016 Oct;27(10):1928-40. doi: 10.1093/annonc/mdw282.
Other Identifiers
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12871
Identifier Type: -
Identifier Source: org_study_id