Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
3 novembre 2020 aggiornato da: Daiichi Sankyo, Inc.
A Randomized, Double-Blind Placebo-Controlled Phase 2 Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who achieved an objective response of Disease Control on first line therapy with Folinic acid (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
84
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Brno, Cechia, 62500
- Fakulti nemocnice Brno
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Olomouc, Cechia, 77520
- Fakultni Nemocnice Olomouc
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Znojmo, Cechia, 66902
- Nemocnice Znojmo, p.o., Oddeleni radiacni a klinicke onkologie
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Moscow, Federazione Russa, 125367
- Central Clinical Hospital #1
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Moscow, Federazione Russa, 115478
- Russian Oncology Research Centre n.a. Blokhin, RAMS
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Moscow, Federazione Russa, 129128
- NUZ Semashko Central Clinical Hospital
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St Petersburg, Federazione Russa, 198255
- St-Petersburg State Institution of Public Health
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St-Petersburg, Federazione Russa, 194291
- Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov
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Tula, Federazione Russa, 300053
- Tula Regional Oncology Dispensary
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Kaluga
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Obninsk, Kaluga, Federazione Russa, 249030
- Medical Radiological Research Centre
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Tatarstan
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Kazan, Tatarstan, Federazione Russa, 4200111
- Kazan State Medical University
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Saint Grégoire, Francia, 35768
- Centre Hospitalier Privé Saint Grégoire
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Cedex
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Colmar, Cedex, Francia, 68024
- Hôpitaux civils de Colmar
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Lyon, Cedex, Francia, 69437
- Hôpital Edouard Herriot
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Rennes, Cedex, Francia, 35042
- Service d'Oncologie Médicale
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Donauwörth, Germania, 86609
- Onkologische Praxis Donauwörth
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Halle, Germania, 06120
- Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin
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München, Germania, 81675
- Klinikum rechts der Isar
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Genova, Italia
- Ospedale San Martino
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Lecce, Italia
- Unita Operativa di Oncologia Medica
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Siena, Italia, 53100
- Policlinico Santa Maria alle Scotte
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Udine, Italia, 33100
- Azienda Ospedaliero Universitaria Santa Maria della Misericordia
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Torino
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Candiolo, Torino, Italia, 10060
- Institute for Cancer Research and Treatment - IRCC
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Bialystok, Polonia, 15-027
- Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
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Bytom, Polonia, 41-902
- Wojewodzki Szpital Specjalistyczny
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Gliwice, Polonia, 44-101
- Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
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Krakow, Polonia, 31-108
- VESALIUS Sp. z o.o.
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Warszawa, Polonia, 01-002
- NZOZ ONKOLOG s.c.
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Aberdeen, Regno Unito, AB25 2ZN
- Aberdeen Royal Infirmary
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London, Regno Unito, EC1A 7BE
- St.Bartholomew's Hospital
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London, Regno Unito, NW1 2PQ
- UCLH Cancer Clinical Trials Unit
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Manchester, Regno Unito, M20 4BX
- Christie Hospital
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Middlesex
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Northwood, Middlesex, Regno Unito, HA6 2RN
- Mount Vernon Cancer Centre
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Pamplona, Spagna, 31008
- Clinica Universitaria de Navarra
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Terrassa (Barcelona), Spagna, 08221
- Hospital Mútua de Terrassa
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Villaroel
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Barcelona, Villaroel, Spagna, 170
- H.Clinic I Provincial de Barcelona
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Kiev, Ucraina, 03115
- Kyiv City Oncology Hospital
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Sumy, Ucraina, 40005
- Sumy Regional Oncology Center
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Volyn
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Lutsk, Volyn, Ucraina
- Volyn Regional Oncology Dispensary
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Patients with histologically confirmed, metastatic CRC that have achieved confirmed maximal benefit of DC following treatment with standard first line chemotherapy of a 5-fluoropyrimidine plus either oxaliplatin or irinotecan. Patients should be entered onto this trial within 8 weeks of completing first line therapy;
- If CR was not achieved: measurable disease, i.e. at minimum one unidimensionally-measurable target lesion according to RECIST (Response Evaluation Criteria in Solid Tumors);
- Age >= 18 years and Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2 at study entry;
- Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 3.0, grade =< 1;
Adequate organ and bone marrow function as evidenced by:
- Haemoglobin >= 10 g/dL (transfusion and/or growth factor support allowed);
- Absolute neutrophil count (ANC) >= 1.5 x 109/L;
- Platelet count >= 100 x 109/L;
- Serum creatinine =< 1.5 x ULN or creatinine clearance >60 mL/min;
- AST and alkaline phosphatase <2.5 x ULN if without liver metastasis and =< 5.0 x ULN if liver metastasis;
- Total bilirubin =< 2.0 x ULN;
- Prothrombin time (PT)/International Normalised Ratio (INR) within normal limits (WNL) unless therapeutically anticoagulated;
- Women of childbearing potential and men must be willing to consent to using highly effective methods of contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter;
- Males with the potential to father children must use two of the following methods of contraception acceptable for the study (e.g. hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on trial treatment and for at least 3 months thereafter.
- All female subjects of childbearing potential must have a negative pregnancy test (plasma or urine) result within 7 days before initiating study treatment;
- Baseline laboratory tests and tumor assessments must have been performed within 2 weeks before initiating study treatment;
- Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC-approved ICF before performance of any study specific procedures or tests.
Exclusion Criteria:
- Anticipation of need for a major surgical procedure or RT during the study;
- Treatment with chemotherapy, hormonal therapy, minor surgery, or any investigational agent within 4 weeks before study enrolment. Treatment with immunotherapy, biological therapy, or major surgery within 6 weeks before study enrolment. Treatment with RT within 1 week before study enrolment.
- History of any of the following conditions: diabetes mellitus requiring treatment with insulin or oral agents;
- Concomitant use of other TZDs;
- Myocardial infarction with significant impairment of cardiac function (e.g., ejection fraction =< 50%); severe/unstable angina pectoris; coronary/peripheral artery bypass graft; congestive heart failure; cerebrovascular accident (CVA) or transient ischemic attack (TIA), pulmonary embolism, or other clinically significant thromboembolic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease [COPD] or asthma);
- Brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis;
- Pleural or pericardial effusion. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor;
- Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy;
- Pregnant or breast feeding;
- Known history of severe hypersensitivity reactions to any of the components of CS 7017 formulations;
- Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment;
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: CS-7017
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CS-7017
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Comparatore placebo: Placebo
Placebo matching CS-7017
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Placebo
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Lasso di tempo: 18 weeks postdose
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Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first.
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.
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18 weeks postdose
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Lasso di tempo: At 12, 24, and 30 weeks postdose
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Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first.
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.
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At 12, 24, and 30 weeks postdose
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Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Lasso di tempo: At 3, 6, 9, and 12 months postdose
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Overall survival (OS) was defined as the time from the date of enrollment to the date of death and assessed by Kaplan Meier analysis.
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At 3, 6, 9, and 12 months postdose
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Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Lasso di tempo: From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months
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The best overall response was defined as the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], unconfirmed CR, unconfirmed PR, stable disease [SD], and progressive disease [PD]) among all overall responses recorded from the start of treatment until the participant withdrew from the study.
If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable.
Based on RECIST v1.0, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
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From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months
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Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Lasso di tempo: From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months
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Duration of response was defined for participants with confirmed CR or PR and confirmed and unconfirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease.
Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease.
Duration of response was estimated using Kaplan Meier methods.
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From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months
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Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Lasso di tempo: Baseline up to 30 days after last study dose, up to 3 years 3 months
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A treatment-emergent adverse event (TEAE) was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment.
If relationship is missing, the AE is also considered to be related to the drug.
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Baseline up to 30 days after last study dose, up to 3 years 3 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
31 luglio 2009
Completamento primario (Effettivo)
29 ottobre 2012
Completamento dello studio (Effettivo)
29 ottobre 2012
Date di iscrizione allo studio
Primo inviato
29 settembre 2009
Primo inviato che soddisfa i criteri di controllo qualità
29 settembre 2009
Primo Inserito (Stima)
30 settembre 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 novembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 novembre 2020
Ultimo verificato
1 novembre 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CS7017-A-E201
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Periodo di condivisione IPD
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Criteri di accesso alla condivisione IPD
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .