Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
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ClinicalTrials.gov Identifier: NCT00986440 |
Recruitment Status
:
Completed
First Posted
: September 30, 2009
Last Update Posted
: April 14, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: CS-7017 Drug: Placebo | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: CS-7017 |
Drug: CS-7017
CS-7017
|
Placebo Comparator: Placebo
Placebo matching CS-7017
|
Drug: Placebo
Placebo
|
- Compare PFS rate of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ]
- Compare overall PFS of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ]
- Compare overall survival of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986440

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 |
Responsible Party: | Daiichi Sankyo, Inc. |
ClinicalTrials.gov Identifier: | NCT00986440 History of Changes |
Other Study ID Numbers: |
CS7017-A-E201 |
First Posted: | September 30, 2009 Key Record Dates |
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 |