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Bladder, Ovarian, Gastric, Colorectal, Lung (Small Cell), Pancreatic, and Lung (Non-Small Cell)

A multinational, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of AVE5026 in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy (EFC6521, SAVE-ONCO)

Unique Data Set IDMultiple_SanofiU_2008_119
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients3212Comparator (Control) Arm Enrolled Patients1604RandomizationYesClinicalTrial.gov ID NCT00694382ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00694382?term=efc6521&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, Placebo, OtherData Set TypeSDTM

Clinical Trial Title

A multinational, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of AVE5026 in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy (EFC6521, SAVE-ONCO)

Trial Summary and Conditions

Study treatment will be administered q.d. s.c. (pre-filled syringes) at approximately 24 hours apart. Study treatment will be administered for the duration of the initial chemotherapy and until decision to change at least one antineoplastic drug (ie, addition or removal; however, in case of antineoplastic dose adjustment only, study medication will continue as planned) due to disease progression or toxicity unless this decision is made within the first 3 months. In case another chemotherapy regimen is started within the first 3 months, the study medication should be continued at least for 3 months (until the end of the regimen ongoing at the Month 3 visit). If the chemotherapy is stopped definitely within the first 3 months, the study medication will be discontinued. At any time during the course of the study, if a patient experiences signs or symptoms evocative of VTE, unscheduled diagnostic test(s) will be performed to confirm or rule out the presence of VTE. For all these events occurring up to 3 calendar days after the last IP injection, a package will be sent to the Central Independent Blinded Adjudication Committee (CIAC) for adjudication. If a PE is discovered incidentally on a lung imaging test for tumor evaluation, a package will be sent to the CIAC for adjudication. All bleeding events and deaths reported up to the follow-up visit will also be adjudicated. Duration of study period per patient is variable depending on study treatment duration. A followup visit is planned one month +/- 1 week after the end of treatment visit. In any case, the study will end at the latest 7 months (6-month treatment period + 1-month follow-up period) following randomization of the last patient (study end date). In addition, survival status (alive, dead, or lost to follow up) will be collected for all patients either one year after randomization or at the end of the study, (ie, 7 months following randomization of the last patient at the latest), whichever comes first.

Data Summary

Datasets contain the 1604 de-identified subjects randomized to the placebo control arm (1583 treated, 21 not treated). Data elements include: demographic, adverse events, cancer diagnosis, concomitant medications, control arm exposure, inclusion/exclusion criteria, laboratory data, medical history, PK, radio and surgical interventions, vital signs, venous thromboembolism (VTE) assessments and study milestone events.

Study Objectives

Primary: To compare the efficacy of semuloparin 20 mg subcutaneous (SC), once daily (QD) with placebo SC QD for the prevention of venous thromboembolism (VTE) in cancer patients at high VTE risk and undergoing chemotherapy. Secondary: To evaluate the safety of semuloparin in cancer patients undergoing chemotherapy, to document semuloparin exposures, to try identifying a metagene predictor of VTE, and to assess the survival status at one year in this population.

Outcome Measures

Primary: Time-to-first occurrence any component of the composite outcome results, confirmed by (CIAC), occurring from randomization up to 3 calendar days after last IP injection: any symptomatic DVT of the lower limbs, any symptomatic DVT of the upper limbs, any nonfatal PE, or any VTE-related deaths (fatal PE or unexplained deaths) Secondary: Initiation of curative anticoagulant or thrombolytic treatment by the Investigator after local VTE assessment, during the efficacy evaluation period. Overall survival (OS) based on the patient survival status that was to be reported either 1 year after randomization, or at study end date (7 months following randomization of the last patient), whichever came first. Major bleeding and clinically relevant nonmajor bleeding (as classified by the CIAC), vital signs, transfusions requirement, hemoglobin, platelet count, liver and renal laboratory data, (serious)adverse events ([S]AEs) and deaths up to the follow up visit.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: sanofi_ave5026_EFC6521_Clinical_Trial_Protocol.pdf

DATA DICTIONARY: sanofi_ave5026_efc6521.xlsx

DATA (COMPARATOR ARM): sanofi_ave5026_README (EFC6521 de-identification notes).docx

DATA (COMPARATOR ARM): AVE5026_EFC6521_data.zip