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Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer (VANGOGH)

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ClinicalTrials.gov Identifier: NCT00753675
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : November 28, 2013
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:
The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Gallbladder Cancer Cancer Of The Extrahepatic Bile Duct Ampullary Carcinoma Drug: ZD6474, Vandetanib Drug: Gemcitabine Drug: Placebo matching ZD6474 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicentre, Phase II, Parallel-Group Trial of Vandetanib Monotherapy or Vandetanib in Combination With Gemcitabine Versus Gemcitabine Plus Vandetanib Matching Placebo in Subjects With Advanced Biliary Tract Cancer (Gallbladder Cancer, Cancer of the Extrahepatic Bile Duct, Intrahepatic Cholangiocarcinoma and Ampullary Carcinoma)
Study Start Date : October 2008
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012


Arm Intervention/treatment
Experimental: A
Vandetanib 300 mg as a once daily oral dose, from Day 1
Drug: ZD6474, Vandetanib
300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Other Name: Zactima

Experimental: B
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
Drug: ZD6474, Vandetanib
100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Other Name: Zactima

Drug: Gemcitabine
administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Other Name: Gemzar

Placebo Comparator: C
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
Drug: Gemcitabine
administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Other Name: Gemzar

Drug: Placebo matching ZD6474
Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: up to 1032 days ]
    Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).


Secondary Outcome Measures :
  1. Objective Tumor Response Rate (CR+PR), [ Time Frame: up to 1032 days ]
    Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD

  2. Disease Control Rate (CR+PR+SD) [ Time Frame: up to 1032 days ]
    DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis

  3. Duration of Response (DOR) [ Time Frame: up to 1032 days ]
    DOR is defined from the date of first documentation of response until date of PD or death

  4. Overall Survival [ Time Frame: up to 1032 days ]
    OS is defined from the date of randomization to death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically-confirmed advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)
  • Patients must have measurable or evaluable but non-measurable disease
  • Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
  • WHO performance status 0 to 2: patients must have a WHO PS ≤ 2

Exclusion Criteria:

  • Patients must not have received prior systemic therapy for advanced (unresectable or metastatic) disease; prior chemotherapy in the adjuvant setting within 3 months before the trial entry is accepted
  • Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance wit
  • Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
  • History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753675


Locations
Italy
Research Site
Brescia, BS, Italy
Research Site
Firenze, FI, Italy
Research Site
Genova, GE, Italy
Research Site
Milano, Mi, Italy
Research Site
Palermo, PA, Italy
Research Site
Aviano, PN, Italy
Research Site
Parma, PR, Italy
Research Site
Reggio Emilia, RE, Italy
Research Site
Ancona, Italy
Research Site
Livorno, Italy
Research Site
Napoli, Italy
Research Site
Pisa, Italy
Research Site
Ravenna, Italy
Research Site
Rho, Italy
Research Site
Torino, Italy
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00753675     History of Changes
Other Study ID Numbers: D4200L00007
EUDRACT n° 2007-003056-12
First Posted: September 16, 2008    Key Record Dates
Results First Posted: November 28, 2013
Last Update Posted: October 10, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Intrahepatic
Cholangiocarcinoma
Vandetanib
Zactima
Advanced
Biliary
Tract
Gallbladder
Extrahepatic Bile Duct
Intrahepatic Cholangiocarcinoma
Ampullary Carcinoma

Additional relevant MeSH terms:
Carcinoma
Cholangiocarcinoma
Gallbladder Neoplasms
Biliary Tract Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs