NCT00597116

Brief Summary

A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2007

Geographic Reach
2 countries

6 active sites

Status
terminated

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

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 15, 2012

Completed
Last Updated

October 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

January 9, 2008

Results QC Date

April 27, 2011

Last Update Submit

August 29, 2016

Conditions

Mesothelioma

Keywords

Mesotheliomainoperablerelapsed

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Disease Control.

    Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.

    Assessed at 2 months.

Secondary Outcomes (3)

  • Number of Participants With Objective Response.

    Assessed at 2 months.

  • Progression-free Survival (PFS)

    Assessed from baseline to 12 months.

  • Overall Survival (OS)

    Assessed from baseline to 12 months.

Study Arms (2)

1

ACTIVE COMPARATOR

Vinorelbine

Drug: Vinorelbine

2

EXPERIMENTAL

Vandetanib

Drug: Vandetanib

Interventions

VinorelbineDRUG
Also known as: Navelbine®
1
VandetanibDRUG

once daily oral dose

Also known as: ZD6474, ZACTIMA™
2

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with mesothelioma
  • Previously treated with only one course of chemotherapy for mesothelioma
  • No previous treatment with vinorelbine
  • No serious heart problems within the last 3 months

You may not qualify if:

  • Serious abnormal laboratory values
  • Severe or uncontrolled disease or condition as judged by the Investigator
  • Pregnant or breast-feeding women
  • Other cancers within the last 5 years
  • Major surgery or radiation therapy within 4 weeks prior to starting study therapy
  • Receipt of any investigational agents within 30 days prior to commencing study treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Essen, Germany

Location

Research Site

Halle-Dolau, Germany

Location

Research Site

Hamburg, Germany

Location

Research Site

Heidelberg, Germany

Location

Research Site

Chur, Switzerland

Location

Research Site

Zurich, Switzerland

Location

MeSH Terms

Conditions

MesotheliomaRecurrence

Interventions

Vinorelbinevandetanib

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Limitations and Caveats

Early termination leading to small number of subjects analyzed.

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi
Contact-US@sanofi.com

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 17, 2008

Study Start

December 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 10, 2016

Results First Posted

October 15, 2012

Record last verified: 2016-08

Locations

DE(4)CH(2)