Clinical trial • Phase III • Oncology

FICLATUZUMAB for Head and neck squamous cell carcinoma (HPV-negative)

Phase III trial of FICLATUZUMAB for Head and neck squamous cell carcinoma (HPV-negative).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Head and neck squamous cell carcinoma (HPV-negative)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
05-12-2023
First CTIS Authorization Date
16-04-2024

Trial design

Randomised, arm 3 (comparator arm: placebo plus cetuximab) (n = 163): iv placebo (saline, ficlatuzumab-matched) on d1 and d15 of each 28-day cycle; iv cetuximab 500 mg/m2 on d1 and d15 of each 28-day cycle-controlled Phase III trial in Bulgaria, Romania, Hungary and others.

Randomised
Yes
Comparator
Arm 3 (Comparator Arm: placebo plus cetuximab) (n = 163): IV placebo (saline, ficlatuzumab-matched) on D1 and D15 of each 28-day cycle; IV cetuximab 500 mg/m2 on D1 and D15 of each 28-day cycle
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
206

Eligibility

Recruits 206 Vulnerable population considerations: participants are adults only (≥18) and must have the ability to give written informed consent. The protocol includes dedicated subject information and informed consent forms (including pregnancy follow-up and pregnant partner information) and pre-ICF telephone consent materials in multiple country languages (see ICF documents). No assent process for minors is applicable (minors excluded)..

Pregnancy Exclusion
17. Female participants who are pregnant or breastfeeding
Vulnerable Population
Vulnerable population considerations: participants are adults only (≥18) and must have the ability to give written informed consent. The protocol includes dedicated subject information and informed consent forms (including pregnancy follow-up and pregnant partner information) and pre-ICF telephone consent materials in multiple country languages (see ICF documents). No assent process for minors is applicable (minors excluded).

Inclusion criteria

  • {"criterion_text":"- 1. Male or female and ≥ 18 years of age\n- 8. Clinical laboratory values meeting the following criteria prior to randomization: a. Serum creatinine clearance > 30 mL/min, using Cockcroft and Gault formula b. Total bilirubin ≤ 1.5 × upper limit of normal (ULN;< 3 × ULN for Gilbert’s disease) c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN, or AST and ALT ≤ 5 × ULN if there are liver metastases d. Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN and prothrombin time/international normalized ratio (PT/INR) ≤ 1.5 × ULN if not on anticoagulation therapy. Participants receiving anticoagulation therapy with an agent such as warfarin, low–molecular weight heparin, or a direct oral anticoagulant (DOAC) may be allowed to participate if the participant is on a stable (≥ 2 weeks) dose of anticoagulant and coagulation test results are in the therapeutic range established prior to initiation of study treatment e. Hematologic function: i. Absolute neutrophil count (ANC) ≥ 1200 cells/μL ii. Hemoglobin (Hgb) ≥ 9 g/dL or 5.6 mmol/L. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dL is acceptable) iii. Platelet count ≥ 75,000/μL\n- 9. For WOCBP, documentation of negative serum pregnancy test within 30 days of randomization\n- 10. For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 5 months after the last dose of study treatment. Birth control methods that may be considered highly effective include methods that achieve a failure rate of less than 1% per year when used consistently and correctly.\n- 6.\tThe patient’s tumor is considered inoperable and incurable in the opinion of the Investigator.\n- 11. Ability to give written informed consent and comply with protocol requirements\n- 12. Patients with feeding tubes are eligible for the study.\n- 13. Archived tissue sample must be submitted to the Sponsor-designated laboratory within 60 daysof randomization for c-Met analysis a. If a tissue sample is not available, the reason should be clearly documented, and a fresh biopsy may be required prior to enrollment after discussion with the Medical Monitor\n- 2. Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC a.\tPrimary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx\n- 3. Participants with oropharyngeal cancer will be required to have proof of p16 negative status submitted on the basis of a pathology report. Equivocal/uncertain test status will not be allowed on trial. a.\tIf p16 status is not known, it is recommended that sites use archived tissue for p16 analysis in participants with oropharyngeal cancer. A report of this analysis must be submitted to confirm eligibility for the study. Note: Per CAP guidelines, p16 positivity is declared when there is at least 70% nuclear and cytoplasmic expression of p16 with at least moderate to strong intensity (Lewis 2018).\n- 4. At least 1 measurable lesion by contrast computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented\n- 5. Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment (if treatment failure was due to intolerance, the patient must have experienced documented progression of disease since the cessation of prior therapy)\n- 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 with a life expectancy of at least 12 weeks"}

Exclusion criteria

  • {"criterion_text":"- 1. Participants who have received >2 prior lines of anticancer therapy or prior treatment with cetuximab/alternative EGFR inhibitors for the treatment of R/M HNSCC a. Cetuximab/EGFR inhibitors in the adjuvant setting are not allowed b. Cetuximab/EGFR inhibitors for the treatment of locally advanced HNSCC is allowed as long as disease recurrence was at least 6 months after the completion of cetuximab/EGFR treatment. c. Participants who progressed within 6 months after treatment with a platinum-based therapy for HNSCC will be considered to have received 1 prior line of treatment for R/M HNSCC.\n- 4. Known or suspected untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis Note: Participants with a history of brain metastases or with suspected brain metastases at Screening must have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry. Participants with locally treated brain metastases are eligible provided 2 weeks have elapsed since local therapy. Any neurologic symptoms that developed either because of brain metastases or their treatment must have resolved or be either stable without the use of steroids or stable on a steroid dose of ≤ 10 mg/day of prednisone or its equivalent. Participants are allowed to continue steroid taper during the start of study treatment.\n- 5. Prior treatment with any other investigational drug or biologic agentor, or radiation therapy before a washout has been completed (must be completed prior to randomization): a. 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors b. 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates c. 4 weeks (28 days) for cell therapiesd.\td. 2 weeks (14 days) for radiation therapy\n- 6. Any unresolved and significant toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) Grade > 2 from previous anticancer therapy (including radiation therapy), other than alopecia\n- 7. Active tumor-related bleeding within the last 30 days that is clinically significant in the opinion of the investigator\n- 8. Significant cardiovascular disease, including: a. Echocardiogram (ECHO) showing left ventricular ejection fraction of less than 45% b. Cardiac failure New York Heart Association class III or IV c. Myocardial infarction, severe or unstable angina within 6 months prior to randomization d. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) e. Significant thrombotic or embolic events within 3 months prior to randomization (significant thrombotic or embolic events include, but are not limited to, stroke or transient ischemic attack). Participants with catheter-related thrombosis, asymptomatic deep vein thrombosis, or asymptomatic pulmonary embolism are not excluded f. Any uncontrolled or severe cardiovascular disease, such as uncontrolled high blood pressure, in the opinion of the investigator\n- 9. Any other medical condition or psychiatric condition that, in the opinion of the investigator, might interfere with the participant’s involvement in the study or interfere with the interpretation of study results\n- 13.\tTreatment with any live or attenuated vaccine within 30 days prior to the first dose of study therapy.\n- 14.\tParticipants who are positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) with indication of acute or chronic hepatitis, as follows: a.\tParticipants who are positive for hepatitis B surface antigen (HBsAg; indicative of chronic HBV or recent acute HBV) are not eligible. b.\tParticipants who are negative for HBsAg and positive for hepatitis B core antibody should undergo assessment of HBV DNA by polymerase chain reaction (PCR); detectable hepatitis B virus DNA suggests occult hepatitis B and warrants exclusion c.\tParticipants who are positive for HCV virus antibody (HCVAb) should undergo assessment of HCV RNA by PCR; detectable HCV RNA suggests chronic HCV and warrants exclusion.\n- 10. History of prior malignancy within 2 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early-stage prostate cancer, without evidence of recurrence; participants may or may not be on maintenance therapy)\n- 11. Major surgery within 2 weeks prior to randomization. This is defined as any surgery involving general anesthesia and ≥ 48 hours of hospital convalescence, or surgery requiring ≥ 2 weeks for recovery. Participants must be fully recovered from surgery. Surgical procedures for placement of an IV shunt are not excluded\n- 12. Serious and/or symptomatic active infection within 14 days prior to first dose of study drug. Participants who have asymptomatic or mild infection and are currently taking a short course of antibiotics (eg, urinary tract infection, bronchitis) may be allowed after discussion with the Medical Monitor\n- 15. Participants on immune-suppressive therapy for organ transplant or participants with a history of genetic or acquired immune suppression disease such as HIV, except: a. Participants with HIV are eligible who have cluster of differentiation 4 (CD4+) T-cell counts > 350 cells/μL without a history of AIDS-defining opportunistic infections; have been on established antiretroviral therapy that does not include a cytochrome P450 3A4 inducer for at least 4 weeks; and have an HIV viral load less than 400 copies/mL\n- 16. Radiographic evidence (historical or at Screening) of ILD or idiopathic pulmonary fibrosis\n- 17. Female participants who are pregnant or breastfeeding\n- 2. Participants with nasopharyngeal cancer or paranasal sinus cancer\n- 3. History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS), defined as the time from the date of randomization to the date of death for any cause","definition_or_measurement_approach":"Defined as the time from the date of randomization to the date of death for any cause"}

Secondary endpoints

  • {"endpoint_text":"- 1. PFS defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) as assessed by the investigator, or death from any cause, whichever occurs first","definition_or_measurement_approach":"Defined as time from randomization to first documented PD per RECIST v1.1 as assessed by investigator, or death from any cause"}
  • {"endpoint_text":"- 2. ORR defined as the percentage of participants who have a complete response (CR) or a partial response (PR) per RECIST v1.1 as assessed by the investigator","definition_or_measurement_approach":"Percentage of participants with confirmed CR or PR per RECIST v1.1 as assessed by investigator"}
  • {"endpoint_text":"- 3. DCR defined as the percentage of participants who have achieved a CR, PR, or stable disease (SD) for at least 8 weeks per RECIST v1.1 (as assessed by the investigator)","definition_or_measurement_approach":"Percentage of participants achieving CR, PR, or SD for ≥8 weeks by RECIST v1.1 as assessed by investigator"}
  • {"endpoint_text":"- 4. Duration of response (DOR), defined for participants who have a confirmed CR or PR as the time from the date of first documented response (which is subsequently confirmed) per RECIST v1.1, as assessed by the investigator, until date of documented PD or death due to any cause, whichever occurs first","definition_or_measurement_approach":"For participants with confirmed CR or PR: time from first documented response (later confirmed) per RECIST v1.1 until documented PD or death"}
  • {"endpoint_text":"- 5. Incidence and severity of adverse events (AEs);\tIncidence and severity of laboratory abnormalities","definition_or_measurement_approach":"Safety assessed by incidence and severity of AEs and laboratory abnormalities (per NCI-CTCAE v5.0)"}
  • {"endpoint_text":"- 6. Concentrations of ficlatuzumab in serum samples","definition_or_measurement_approach":"Pharmacokinetic assessment: serum concentration measurements of ficlatuzumab"}
  • {"endpoint_text":"- 7. The presence of antidrug antibodies (ADA) to ficlatuzumab based on seroconversion status, and the evaluation of the potential impact of ADA on PK, efficacy, and safety •\tThe presence of neutralizing antibodies, when ADA is positive, and the evaluation of the potential interference of ADA on ficlatuzumab-HGF binding","definition_or_measurement_approach":"Immunogenicity assessed by ADA seroconversion; if ADA positive, presence of neutralizing antibodies and evaluation of impact on PK, efficacy and safety and potential interference with ficlatuzumab-HGF binding"}
  • {"endpoint_text":"- 8. Change from baseline in the European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-Head and Neck Module 35 (H&N35) •\tTime to clinically meaningful deterioration in scores on the EORTC H&N35 •\tChange from baseline in overall health status per the EuroQol-5 dimensions-3 level (EQ-5D-3L)","definition_or_measurement_approach":"Patient-reported outcomes: change from baseline and time to clinically meaningful deterioration on EORTC QLQ-H&N35; change from baseline in EQ-5D-3L overall health status"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
206
Recruitment Window Months
38
Consent Approach
Written informed consent is required from each participant (must be able to give written informed consent). Country-specific subject information and consent forms are provided (multiple language versions present: e.g., English, Bulgarian, Romanian, French, Dutch, Hungarian, Italian, German, Polish, Spanish). Pre-ICF telephone data-consent materials are included to support telephone pre-screening and consent processes. Specific pregnancy follow-up and pregnant-partner information/ICFs are provided for WOCBP.

Methods

  • Physician referral letters (documented physician referral letter templates included in recruitment materials)
  • Pre-ICF telephone data consent (telephone pre-screen / pre-ICF consent materials included)
  • Site recruitment arrangements and patient-facing brochures / patient cards (country-specific K1/K2 recruitment documents present)
  • Digital recruitment materials via Scout platform (Scout brochures, ScoutPass mailer and other Scout materials referenced for some countries, e.g., Hungary)

Geography

Total Number Of Sites
51
Total Number Of Participants
206

Bulgaria

Earliest CTIS Part Ii Submission Date
05-04-2024
Latest Decision Or Authorization Date
29-04-2025
Processing Time Days
389
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department Name
Medical oncology department
Contact Person Name
Rossitza Krasteva
Contact Person Email
rkr_2002@yahoo.com

Romania

Earliest CTIS Part Ii Submission Date
03-01-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
768
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncology
Contact Person Name
Andrei Ungureanu
Site Name
Medisprof S.R.L.
Department Name
Oncology
Contact Person Name
Adrian Anghel Udrea
Contact Person Email
adrianudrea@medisprof.ro

Hungary

Earliest CTIS Part Ii Submission Date
27-03-2024
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
679
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Szent Lazar Megyei Korhaz
Department Name
Oncology
Contact Person Name
Lazlo Landherr
Contact Person Email
landherr@szlmk.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Oncology
Contact Person Name
Tamas Pinter
Contact Person Email
pinter.tamas@oncol.hu
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Oncology
Contact Person Name
Agnes Weber
Contact Person Email
agneswebermd@gmail.com
Site Name
University Of Pecs
Department Name
Oncology
Contact Person Name
Szabolcs Bellyei
Contact Person Email
bellyei.szabolcs@pte.hu

Netherlands

Earliest CTIS Part Ii Submission Date
31-03-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
674
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Stichting Radboud University Medical Center
Department Name
Oncology
Contact Person Name
Caroline (Carla) van Herpen
Contact Person Email
carla.vanherpen@radboudumc.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Oncology
Contact Person Name
Jean Paul De Boer
Contact Person Email
j.d.boer@nki.nl

Belgium

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
687
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Vitaz
Department Name
Oncologie
Contact Person Name
Willem Lybaert
Contact Person Email
willem.lybaert@telenet.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncologie
Contact Person Name
Henry Stephanie
Site Name
CHU De Liege
Department Name
Oncologie
Contact Person Name
Aurelie Poncin
Contact Person Email
aponcin@chuliege.be

Italy

Earliest CTIS Part Ii Submission Date
27-03-2024
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
679
Number Of Sites
10
Number Of Participants
40

Sites

Site Name
Humanitas Research Hospital
Department Name
Operating Unit of Oncology and Hematology
Contact Person Name
Paolo Bossi
Contact Person Email
Paolo.bossi@hunimed.eu
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Oncology 1
Contact Person Name
Ilaria Imarisio
Contact Person Email
i.imarisio@smatteo.pv.it
Site Name
Careggi University Hospital
Department Name
SOD Radioterapia Oncologica
Contact Person Name
Lorenzo Livi
Contact Person Email
Lorenzo.livi@unifi.it
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
UOC Oncologia del Sistema Nervoso
Contact Person Name
Alicia Tosoni
Contact Person Email
a.tosoni@isnb.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica 3
Contact Person Name
Lisa Licitra
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO Oncologia Medica
Contact Person Name
Aurora Mirabile
Contact Person Email
Mirabile.aurora@hsr.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oncologia Medica
Contact Person Name
Alessandra Cassano
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncology 2
Contact Person Name
Maria Grazia Ghi
Contact Person Email
Mariagrazia.ghi@iov.veneto.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Oncologia
Contact Person Name
Andrea Sponghini
Site Name
Istituti Clinici Scientifici Maugeri
Department Name
Oncologia Medica
Contact Person Name
Laura Debora Locati

France

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
690
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Clinique Pasteur Lanroze
Department Name
Oncologie
Contact Person Name
Ali HASBINI
Contact Person Email
alihasbini@oncologie-brest.fr
Site Name
Institut Curie
Department Name
Oncologie
Contact Person Name
Edith BORCOMAN
Contact Person Email
edith.borcoman@curie.fr
Site Name
Hopital Prive Des Cotes D'armor
Department Name
Oncologie
Contact Person Name
Dominique BESSON
Contact Person Email
d.besson@cario-sante.fr
Site Name
Centre Leon Berard
Department Name
Oncologie
Contact Person Name
Jérôme FAYETTE
Site Name
Institut Gustave Roussy
Department Name
Oncologie
Contact Person Name
Caroline EVEN
Contact Person Email
Caroline.EVEN@gustaveroussy.fr
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Oncologie
Contact Person Name
Sébastien SALAS
Contact Person Email
Sebastien.SALAS@ap-hm.fr
Site Name
Pole Sante Leonard De Vinci
Department Name
Oncologie
Contact Person Name
Pierre COMBE
Contact Person Email
p.combe@cort37.fr

Poland

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
08-02-2026
Processing Time Days
682
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Żurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Badawczy oddział w Gliwicach
Contact Person Name
Tomasz Rutkowski

Germany

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
688
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Medical Center - University Of Freiburg
Department Name
Department of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation
Contact Person Name
Justyna Katarzyna Rawluk
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Department of Medical Oncology and Hematology
Contact Person Name
Volker Heinemann
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department for medical oncology, hematology and internal medicine
Contact Person Name
Konrad Klinghammer
Contact Person Email
konrad.klinghammer@charite.de

Czechia

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
691
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Ústav radiační onkologie
Contact Person Name
Petra Holečková
Contact Person Email
petra.holeckova@bulovka.cz
Site Name
Fakultní Nemocnice Královské Vinohrady
Department Name
Onkologická klinika
Contact Person Name
Kateřina Licková
Contact Person Email
katerina.lickova@fnkv.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a a onkologická klinika
Contact Person Name
Zdeněk Král
Contact Person Email
kral.zdenek@fnbrno.cz

Spain

Earliest CTIS Part Ii Submission Date
02-04-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
748
Number Of Sites
13
Number Of Participants
40

Sites

Site Name
Hospital De Jerez De La Frontera
Department Name
Oncology
Contact Person Name
Silvia Patricia Silva Romeiro
Contact Person Email
silviaromeiro109@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Contact Person Name
Marta Sotelo
Contact Person Email
marta.sotelo@scsalud.es
Site Name
Hospital Universitario Del Vinalopo
Department Name
Ortiz
Contact Person Name
Pablo Salces
Contact Person Email
psalces@vinaloposalud.com
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Beatriz Castelo Fernandez
Contact Person Email
castelobeatriz@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Oncology
Contact Person Name
Beatriz Cirauqui Cirauqui
Contact Person Email
bcirauqui@iconcologia.net
Site Name
Vall D'hebron Institut De Recerca
Department Name
Oncology
Contact Person Name
Irene Braña García
Contact Person Email
ibrana@vhio.net
Site Name
Hospital Quironsalud Malaga
Department Name
Oncology
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuel.cobo.co@quironsalud.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Sandra Llop Serna
Contact Person Email
sandrallop@iconcologia.net
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Oncology
Contact Person Name
Jaime Berrocal
Contact Person Email
berrocal.alf@gmail.com
Site Name
Micancer Center S.L.P.
Department Name
Oncology
Contact Person Name
Carlos Cabrera Galvez
Contact Person Email
ccabrera@uomi.es
Site Name
Hospital Universitario De Torrejon
Department Name
Oncology
Contact Person Name
Luis Cabezon Gutierrez
Contact Person Email
lcabezon@torrejonsalud.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Rafael Álvarez Gallego
Site Name
Hospital Universitario Del Vinalopo (additional site entry)
Department Name
Oncology

Sponsor

Primary sponsor

Full Name
Aveo Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Worldwide Clinical Trials
Responsibilities
Extensive CRO responsibilities (multiple codes listed in sponsor duties)
Name
PPD Development LP
Responsibilities
Clinical trial related activities (sponsor duties code 4)
Name
Parexel International (IRL) Limited
Responsibilities
Clinical trial related activities (sponsor duties code 8)
Name
LabCorp Central Laboratory Services LP / S.a.r.l.
Responsibilities
Central laboratory services
Name
Medidata Solutions Inc.
Responsibilities
Electronic data capture / data systems

Third parties

  • {"country":"United Kingdom","full_name":"Image Analysis Limited","duties_or_roles":"Image Analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Worldwide Clinical Trials In Breve Wct S.r.l.","duties_or_roles":"All activities related to the CRO in regards with Italy","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"LabCorp Development (Asia) Pte. Ltd.","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Croatia","full_name":"Worldwide Clinical Trials","duties_or_roles":"Multiple CRO-related activities (codes provided in sponsor duties)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Ficlatuzumab
Active Substance
FICLATUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Not marketed / sponsor product (sponsorProductCode: AV-299)
Starting Dose
10 mg/kg and 20 mg/kg (two investigational dose arms)
Dose Levels
10 mg/kg; 20 mg/kg
Frequency
D1 and D15 of each 28-day cycle
Maximum Dose
20 mg/kg
Dose Escalation Increase
Initial 10 mg/kg; higher dose 20 mg/kg
Investigational Product Name
Erbitux 5 mg/mL solution for infusion (cetuximab)
Active Substance
CETUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Marketing authorisation EU/1/04/281/003
Starting Dose
Cetuximab 500 mg/m2
Dose Levels
500 mg/m2
Frequency
D1 and D15 of each 28-day cycle
Maximum Dose
Max daily dose reported 500 mg/m2; max total dose amount 12000 (as per product data)
Investigational Product Name
Placebo (0.9% Sodium Chloride injection, site-provided)
Modality
Other
Authorisation Status
N/A (site-provided saline placebo)
Frequency
D1 and D15 of each 28-day cycle (placebo matched to ficlatuzumab schedule)
Combination Treatment
Yes

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