Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Drug: CS-7017; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	86 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	July 2009
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	January 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: CS-7017	Drug: CS-7017; CS-7017
Placebo Comparator: Placebo; Placebo matching CS-7017	Drug: Placebo; Placebo

Outcome Measures

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Primary Outcome Measures :

1. Compare PFS rate of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ]

Secondary Outcome Measures :

1. Compare overall PFS of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ]
2. Compare overall survival of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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;

Contacts and Locations

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Locations

Czech Republic
Fakulti nemocnice Brno
Brno, Czech Republic, 62500
Fakultni nemocnice Olomouc
Olomouc, Czech Republic, 77520
Nemocnice Znojmo, p.o., Oddeleni radiacni a klinicke onkologie
Znojmo, Czech Republic, 66902
France
Hopitaux civils de colmar
Colmar, Cedex, France, 68024
Hopital Edouard Herriot
Lyon, Cedex, France, 69437
Service d'Oncologie Medicale
Rennes, Cedex, France, 35042
Centre Hospitalier Prive Saint Gregoire
Saint Grégoire, France, 35768
Germany
Onkologische Praxis Donauwörth
Donauwörth, Germany, 86609
Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin
Halle, Germany, 06120
Klinikum rechts der Isar
München, Germany, 81675
Italy
Institute for Cancer Research and Treatment - IRCC
Candiolo, Torino, Italy, 10060
Ospedale San Martino
Genova, Italy
Unita Operativa di Oncologia Medica
Lecce, Italy
Policlinico Santa Maria alle Scotte
Siena, Italy, 53100
Azienda Ospedaliero Universitaria Santa Maria della Misericordia
Udine, Italy, 33100
Poland
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
Bialystok, Poland, 15-027
Wojewodzki Szpital Specjalistyczny
Bytom, Poland, 41-902
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
Gliwice, Poland, 44-101
VESALIUS Sp. z o.o.
Krakow, Poland, 31-108
NZOZ ONKOLOG s.c.
Warszawa, Poland, 01-002
Russian Federation
Medical Radiological Research Centre
Obninsk, Kaluga, Russian Federation, 249030
Kazan State Medical University
Kazan, Tatarstan, Russian Federation, 4200111
Russian Oncology Research Centre n.a. Blokhin, RAMS
Moscow, Russian Federation, 115478
Central Clinical Hospital #1
Moscow, Russian Federation, 125367
NUZ Semashko Central Clinical Hospital
Moscow, Russian Federation, 129128
St-Petersburg State Institution of Public Health
St Petersburg, Russian Federation, 198255
Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov
St-Petersburg, Russian Federation, 194291
Tula Regional Oncology dispensary
Tula, Russian Federation, 300053
Spain
H.Clinic I Provincial de Barcelona
Barcelona, Villaroel, Spain, 170
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Mútua de Terrassa
Terrassa (Barcelona), Spain, 08221
Ukraine
Volyn regional oncology dispensary
Lutsk, Volyn, Ukraine
Kyiv City Oncology Hospital
Kiev, Ukraine, 03115
Sumy Regional Oncology Center
Sumy, Ukraine, 40005
United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom, HA6 2RN
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
St.Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
UCLH Cancer Clinical Trials Unit
London, United Kingdom, NW1 2PQ
Christie Hospital
Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Daiichi Sankyo, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:	NCT00986440 History of Changes
Other Study ID Numbers:	CS7017-A-E201
First Posted:	September 30, 2009
Last Update Posted:	April 14, 2015
Last Verified:	April 2015

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases	Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Efatutazone; Antineoplastic Agents