NCT00507091

Brief Summary

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Typical duration for phase_1

Geographic Reach
2 countries

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

Study Start

First participant enrolled

August 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

July 10, 2007

Last Update Submit

August 24, 2016

Conditions

MetastaticColorectalAdenocarcinoma

Keywords

ZD6474Irinotecan5-FluorouracilLeucovorincolorectal

Outcome Measures

Primary Outcomes (1)

  • Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations

    assessed at each visit

Study Arms (2)

ZD6474 (vandetanib) 100mg

EXPERIMENTAL
Drug: ZD6474 (vandetanib) 100mgDrug: IrinotecanDrug: 5-FluorouracilDrug: Leucovorin

ZD6474 (vandetanib) 300mg

EXPERIMENTAL
Drug: IrinotecanDrug: 5-FluorouracilDrug: LeucovorinDrug: ZD6474 (vandetanib) 300mg

Interventions

ZD6474 (vandetanib) 100mgDRUG

once daily oral tablet

Also known as: ZACTIMA™
ZD6474 (vandetanib) 100mg
IrinotecanDRUG

intravenous infusion

Also known as: Camptosar®
ZD6474 (vandetanib) 100mgZD6474 (vandetanib) 300mg
5-FluorouracilDRUG

intravenous infusion

Also known as: 5-FU
ZD6474 (vandetanib) 100mgZD6474 (vandetanib) 300mg
LeucovorinDRUG

intravenous infusion

ZD6474 (vandetanib) 100mgZD6474 (vandetanib) 300mg
ZD6474 (vandetanib) 300mgDRUG

once daily oral tablet

Also known as: ZACTIMA™
ZD6474 (vandetanib) 300mg

Eligibility Criteria

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

You may qualify if:

  • Confirmed metastatic colorectal adenocarcinoma
  • Not amenable to surgery or radiation therapy
  • Eligible for first or second line chemotherapy

You may not qualify if:

  • Brain metastases or spinal compression
  • Last prior chemotherapy discontinued within 4 weeks before start
  • Last dose radiotherapy within 4 weeks of start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Ghent, Belgium

Location

Research Site

Belfast, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Related Publications (1)

  • Saunders MP, Wilson R, Peeters M, Smith R, Godwood A, Oliver S, Van Cutsem E. Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. Cancer Chemother Pharmacol. 2009 Sep;64(4):665-72. doi: 10.1007/s00280-008-0914-4. Epub 2009 Jan 29.

    PMID: 19184020BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisAdenocarcinoma

Interventions

vandetanibIrinotecanFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 25, 2007

Study Start

August 1, 2005

Primary Completion

May 1, 2006

Study Completion

June 1, 2008

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

GB(2)BE(1)