Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

NCT00753675 | Completed Phase 2 Results

• 2 other identifiers: D4200L00007EUDRACT n° 2007-003056-12
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 15

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.

Conditions

Biliary Tract Cancer; Gallbladder Cancer; Cancer Of The Extrahepatic Bile Duct; Ampullary Carcinoma

Keywords

Intrahepatic; Cholangiocarcinoma; Vandetanib; Zactima; Advanced; Biliary; Tract; Gallbladder; Extrahepatic Bile Duct; Intrahepatic Cholangiocarcinoma; Ampullary Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  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of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the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).

  up to 1032 days

Secondary Outcomes (4)

• Objective Tumor Response Rate (CR+PR),

  up to 1032 days

• Disease Control Rate (CR+PR+SD)

  up to 1032 days

• Duration of Response (DOR)

  up to 1032 days

• Overall Survival

  up to 1032 days

Study Arms (3)

A

EXPERIMENTAL

Vandetanib 300 mg as a once daily oral dose, from Day 1

Drug: ZD6474, Vandetanib

B

EXPERIMENTAL

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; Drug: Gemcitabine

C

PLACEBO COMPARATOR

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; Drug: Placebo matching ZD6474

Interventions

ZD6474, Vandetanib DRUG

300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Also known as: Zactima

A

Gemcitabine DRUG

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

Also known as: Gemzar

B; C

Placebo matching ZD6474 DRUG

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

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (15)

Research Site

Brescia, BS, Italy

Location

Research Site

Florence, FI, Italy

Location

Research Site

Genova, GE, Italy

Location

Research Site

Milan, Mi, Italy

Location

Research Site

Palermo, PA, Italy

Location

Research Site

Aviano, PN, Italy

Location

Research Site

Parma, PR, Italy

Location

Research Site

Reggio Emilia, RE, Italy

Location

Research Site

Ancona, Italy

Location

Research Site

Livorno, Italy

Location

Research Site

Napoli, Italy

Location

Research Site

Pisa, Italy

Location

Research Site

Ravenna, Italy

Location

Research Site

Rho, Italy

Location

Research Site

Torino, Italy

Location

Related Publications (2)

• Wedge SR, Ogilvie DJ, Dukes M, Kendrew J, Chester R, Jackson JA, Boffey SJ, Valentine PJ, Curwen JO, Musgrove HL, Graham GA, Hughes GD, Thomas AP, Stokes ES, Curry B, Richmond GH, Wadsworth PF, Bigley AL, Hennequin LF. ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res. 2002 Aug 15;62(16):4645-55.

  PMID: 12183421 BACKGROUND

• Santoro A, Gebbia V, Pressiani T, Testa A, Personeni N, Arrivas Bajardi E, Foa P, Buonadonna A, Bencardino K, Barone C, Ferrari D, Zaniboni A, Tronconi MC, Carteni G, Milella M, Comandone A, Ferrari S, Rimassa L. A randomized, multicenter, phase II study of vandetanib monotherapy versus vandetanib in combination with gemcitabine versus gemcitabine plus placebo in subjects with advanced biliary tract cancer: the VanGogh study. Ann Oncol. 2015 Mar;26(3):542-7. doi: 10.1093/annonc/mdu576. Epub 2014 Dec 23.

  PMID: 25538178 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms; Gallbladder Neoplasms; Cholangiocarcinoma

Interventions

vandetanib; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 10, 2016
• Results First Posted: November 28, 2013

Record last verified: 2016-08

Locations

IT (15)