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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00574275
Other study ID # EFC10547
Secondary ID EudraCT 2007-003
Status Terminated
Phase Phase 3
First received December 14, 2007
Last updated September 24, 2012
Start date December 2007
Est. completion date November 2010

Study information

Verified date July 2011
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationItaly: Ministry of HealthPoland: Ministry of Health
Study type Interventional

Clinical Trial Summary

The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine.

The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).

The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.


Description:

The study included:

- A screening visit of up to 21 days prior to randomization

- Randomization at baseline

- A Treatment period (initiated within 3 days of randomization), which included 28-day treatment cycles in both arms until predefined treatment discontinuation criteria were met

- A follow-up visit 30 days after discontinuation of treatment,

- A post study treatment follow-up period until death or the study cutoff date.

The criteria for treatment discontinuation were:

- Participant (or legal representative) chose to withdraw from treatment

- The investigator thought that continuation of the study would be detrimental to the participants well-being, such as:

- Disease progression

- Unacceptable AEs not manageable by symptomatic therapy, dose delay, or dose modification

- Intercurrent illness that prevented further administration of study treatment

- Noncompliance with the study protocol

- Participant was lost to follow-up

- Unblinding of the participant's investigational treatment


Recruitment information / eligibility

Status Terminated
Enrollment 546
Est. completion date November 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas

- Metastatic disease

- No prior chemotherapy for pancreatic disease

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

- Adequate renal, liver and bone marrow functions

Exclusion Criteria:

- Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of randomization

- Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors

- Uncontrolled hypertension

- Pregnancy or breastfeeding

- Participant with reproductive potential (M/F) without effective method of contraception

The above information is not intended to contain all considerations relevant to potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Placebo
4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle
Gemcitabine
1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles.

Locations

Country Name City State
Argentina Sanofi-Aventis Administrative Office Buenos Aires
Austria Sanofi-Aventis Administrative Office Wien
Belgium Sanofi-Aventis Administrative Office Diegem
Bulgaria Sanofi-Aventis Administrative Office Sofia
Canada Sanofi-Aventis Administrative Office Laval
Chile Sanofi-Aventis Administrative Office Santiago
Colombia Sanofi-Aventis Administrative Office Santafe de Bogota
Cyprus Sanofi-Aventis Administrative Office Nikosia
Czech Republic Sanofi-Aventis Administrative Office Praha
France Sanofi-Aventis Administrative Office Paris
Germany Sanofi-Aventis Administrative Office Berlin
Greece Sanofi-Aventis Administrative Office Athens
Hungary Sanofi-Aventis Administrative Office Budapest
India Sanofi-Aventis Administrative Office Mumbai
Italy Sanofi-Aventis Administrative Office Milano
Mexico Sanofi-Aventis Administrative Office Mexico
Poland Sanofi-Aventis Administrative Office Warszawa
Puerto Rico Sanofi-Aventis Administrative Office Puerto Rico
Romania Sanofi-Aventis Administrative Office Bucuresti
Russian Federation Sanofi-Aventis Administrative Office Moscow
Slovakia Sanofi-Aventis Administrative Office Brastislava
Spain Sanofi-Aventis Administrative Office Barcelona
Switzerland Sanofi-Aventis Administrative Office Geneva
United States Sanofi-Aventis Administrative Office Bridgewater New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  Colombia,  Cyprus,  Czech Republic,  France,  Germany,  Greece,  Hungary,  India,  Italy,  Mexico,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) OS is the time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, data on OS were censored at the earlier of the last date participant was known to be alive, or the study data cutoff date (11 September 2009).
OS time was estimated from Kaplan-Meier Plots.
From the first randomization until the end of study data cutoff date (approximately 2 years) No
Secondary Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria PFS was the time interval from the date of registration to the date of progression, or death from any cause if it occurs before tumor progression is documented. Tumor progression was assessed using RECIST criteria, by which progression was a pre-defined increase in the size of existing tumors or appearance of one or more new tumors.
If a participant did not progress or die, the progression was censored to the date of the last valid tumor assessment or data cut-off, whichever was earlier.
Median PFS time was estimated from Kaplan-Meier Plots.
From the first randomization until the end of study data cutoff date (approximately 2 years) No
Secondary Objective Response Rate (ORR) Assessed by the Investigators According to RECIST Criteria Objective response (OR) included complete response [CR] and partial response [PR]. OR was to be assessed by the Investigators according to RECIST criteria, and confirmed by repeating tumor imaging at least 4 weeks after the first radiological documentation of response.
CR would reflect the disappearance of all tumor lesions and PR would reflect a defined reduction of tumor burden.
However, OR analysis was not performed, as the study was terminated due to futility.
From the first randomization until the end of the study data cutoff date (approximately 2 years) No
Secondary Clinical Benefit Clinical benefit was to be assessed in all participants by time to symptom worsening (TTSW), evaluated from the time of randomization to symptom worsening, as well as by improvement in tumor related symptoms.
However, this analysis was not performed, as the study was terminated due to futility.
From the first randomization until the end of the study data cutoff date (approximately 2 years) No
Secondary Safety-Number of Participants With Adverse Events (AE) All AEs regardless of seriousness or relationship to study treatment, spanning from the signature of informed consent until 30 days after the last administration of study treatment, were recorded. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported. up to 30 days after treatment discontinuation. SAEs and related AEs were followed till resolved or stabilized. Yes
Secondary Number of Participants With Anti-drug Antibodies Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. The validated lower limit of detection (LLOD) for the assay was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 µg/mL of aflibercept. Up to 90 days post last dose of study drug No
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