NCT00562913

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

2 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

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

1.5 years

First QC Date

November 21, 2007

Last Update Submit

November 24, 2013

Conditions

Cancer

Keywords

CancerSorafenibCyclophosphamideDoxorubicin

Outcome Measures

Primary Outcomes (1)

  • To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered

    6 weeks

Secondary Outcomes (1)

  • To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib

    6 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Nexavar (Sorafenib, BAY43-9006)

Interventions

Nexavar (Sorafenib, BAY43-9006)DRUG

Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin

Arm 1

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • \> 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Edmonton, Alberta, T6G 1Z2, Canada

Location

Unknown Facility

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

December 1, 2007

Primary Completion

June 1, 2009

Study Completion

March 1, 2010

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

CA(2)