NCT00962611

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

November 19, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2016

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

6.3 years

First QC Date

August 19, 2009

Last Update Submit

October 5, 2017

Conditions

Neoplasms

Keywords

Solid tumorsAdvanced cancer

Outcome Measures

Primary Outcomes (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.

    2 years

Secondary Outcomes (2)

  • 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

Study Arms (1)

Copanlisib

EXPERIMENTAL
Drug: Copanlisib (Aliqopa, BAY80-6946)

Interventions

Copanlisib (Aliqopa, BAY80-6946)DRUG

BAY80-6946 given IV over 1 hour every week for three weeks with a one week break until progression or unacceptable toxicities develop.

Copanlisib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Scottsdale, Arizona, 85258, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

San Antonio, Texas, 78229-3307, United States

Location

Related Publications (3)

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

    BACKGROUND

  • 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.

    PMID: 5035790RESULT

  • 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.

    PMID: 27672108DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

copanlisib

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 20, 2009

Study Start

November 19, 2009

Primary Completion

February 23, 2016

Study Completion

February 23, 2016

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

US(3)