Phase I Study of Sorafenib Dosed Continuously With Cyclop... | NCT00562913

Studies
Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

NCT00562913

Sponsor

Bayer

Status

Completed

Last Update Posted

Nov 26, 2013Estimated

Enrollment

21Actual

Phase

Phase 1

Conditions

Cancer

Interventions

Nexavar (Sorafenib, BAY43-9006)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Phase I Open-label, Non-randomized, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Tumor Response Profile of Sorafenib as Continuous Dosing in Combination With Cyclophosphamide and Doxorubicin in Patients With Advanced, Refractory Solid Tumors

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Nov 21, 2007

First Submission Date that Met QC Criteria

Nov 22, 2007

First Posted Date

Nov 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2013

Last Update Posted Date

Nov 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Nexavar (Sorafenib, BAY43-9006)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nexavar (Sorafenib, BAY43-9006)	Drug	Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years old
Advanced histological or cytological documentation of cancer
life-expectancy of at least 12 weeks
able to swallow pills
ECOG status of 0,1 or 2
adequate bone marrow
liver and renal function

Exclusion Criteria:

> NYHA Class 2 CHF
Serious myocardial dysfunction,
or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed)
History of organ allograft
uncontrolled hypertension
renal dialysis
Bleeding event/hemorrhage within 4 weeks of study treatment
major surgery within 4 weeks of study treatment
Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077157	Sorafenib

Ancestor Terms

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Edmonton	Alberta	T6G 1Z2	Canada