NCT00686036

Brief Summary

The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

11 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

May 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
8 months until next milestone

Results Posted

Study results publicly available

May 24, 2011

Completed
Last Updated

December 21, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

May 27, 2008

Results QC Date

April 27, 2011

Last Update Submit

October 27, 2016

Conditions

Prostate Cancer

Keywords

prostate cancerhormone treatment

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)

    52 weeks

Secondary Outcomes (3)

  • Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)

    78 weeks during off-treatment phase of ADT

  • Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)

    From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL

  • Serum Testosterone Levels

    Change from baseline at each visit post-randomization until until week 78

Study Arms (2)

vandetanib

EXPERIMENTAL

300 mg orally, once daily for up to 18 months

Drug: vandetanib

Placebo

PLACEBO COMPARATOR

orally, once daily for up to 18 months

Drug: Placebo

Interventions

vandetanibDRUG

300 mg orally, once daily for up to 18 months

Also known as: Zactima
vandetanib
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of prostate cancer
  • Prostate specific antigen (PSA) greater than or equal to 5 ng/mL
  • Recent completion of first hormone treatment \[intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue\]
  • Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)

You may not qualify if:

  • Bone or soft tissue metastases
  • Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Calgary, Alberta, Canada

Location

Research Site

Edmonton, Alberta, Canada

Location

Research Site

Victoria, British Columbia, Canada

Location

Research Site

Hamilton, Ontario, Canada

Location

Research Site

Kingston, Ontario, Canada

Location

Research Site

London, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Greenfield Park, Quebec, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Sherbrooke, Quebec, Canada

Location

Research Site

Granby, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Limitations and Caveats

It was planned that approx 100 patients would be recruited over a period of approx 2 years, due to slow recruitment the study was terminated early. No statistical analyses was done and no conclusion can be drawn about the outcomes in this study.

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

May 1, 2008

Primary Completion

April 1, 2010

Study Completion

October 1, 2010

Last Updated

December 21, 2016

Results First Posted

May 24, 2011

Record last verified: 2016-10

Locations

CA(11)