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

NCT00986440 | Terminated Phase 2 Results

• 1 other identifier: CS7017-A-E201
• Study Type: interventional
• Target: 84
• Locations: 9 countries
• Sites: 39

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  18 weeks postdose

Secondary Outcomes (5)

• Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

  At 12, 24, and 30 weeks postdose

• Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

  At 3, 6, 9, and 12 months postdose

• 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

  From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months

• Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

  From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months

• 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

  Baseline up to 30 days after last study dose, up to 3 years 3 months

Study Arms (2)

CS-7017

EXPERIMENTAL

Drug: CS-7017

Placebo

PLACEBO COMPARATOR

Placebo matching CS-7017

Drug: Placebo

Interventions

CS-7017 DRUG

CS-7017

CS-7017

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (39)

Fakulti nemocnice Brno

Brno, 62500, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 77520, Czechia

Location

Nemocnice Znojmo, p.o., Oddeleni radiacni a klinicke onkologie

Znojmo, 66902, Czechia

Location

Hopitaux civils de colmar

Colmar, Cedex, 68024, France

Location

Hopital Edouard Herriot

Lyon, Cedex, 69437, France

Location

Service d'Oncologie Medicale

Rennes, Cedex, 35042, France

Location

Centre Hospitalier Prive Saint Gregoire

Saint-Grégoire, 35768, France

Location

Onkologische Praxis Donauwörth

Donauwörth, 86609, Germany

Location

Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin

Halle, 06120, Germany

Location

Klinikum rechts der Isar

München, 81675, Germany

Location

Institute for Cancer Research and Treatment - IRCC

Candiolo, Torino, 10060, Italy

Location

Ospedale San Martino

Genova, Italy

Location

Unita Operativa di Oncologia Medica

Lecce, Italy

Location

Policlinico Santa Maria alle Scotte

Siena, 53100, Italy

Location

Azienda Ospedaliero Universitaria Santa Maria della Misericordia

Udine, 33100, Italy

Location

Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku

Bialystok, 15-027, Poland

Location

Wojewodzki Szpital Specjalistyczny

Bytom, 41-902, Poland

Location

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

Gliwice, 44-101, Poland

Location

VESALIUS Sp. z o.o.

Krakow, 31-108, Poland

Location

NZOZ ONKOLOG s.c.

Warsaw, 01-002, Poland

Location

Medical Radiological Research Centre

Obninsk, Kaluga Oblast, 249030, Russia

Location

Kazan State Medical University

Kazan', Tatarstan Republic, 4200111, Russia

Location

Russian Oncology Research Centre n.a. Blokhin, RAMS

Moscow, 115478, Russia

Location

Central Clinical Hospital #1

Moscow, 125367, Russia

Location

NUZ Semashko Central Clinical Hospital

Moscow, 129128, Russia

Location

Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov

Saint Petersburg, 194291, Russia

Location

St-Petersburg State Institution of Public Health

Saint Petersburg, 198255, Russia

Location

Tula Regional Oncology dispensary

Tula, 300053, Russia

Location

H.Clinic I Provincial de Barcelona

Barcelona, Villaroel, 170, Spain

Location

Clinica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Hospital Mútua de Terrassa

Terrassa (Barcelona), 08221, Spain

Location

Volyn regional oncology dispensary

Lutsk, Volyn Oblast, Ukraine

Location

Kyiv City Oncology Hospital

Kiev, 03115, Ukraine

Location

Sumy Regional Oncology Center

Sumy, 40005, Ukraine

Location

Mount Vernon Cancer Centre

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

St.Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

UCLH Cancer Clinical Trials Unit

London, NW1 2PQ, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

efatutazone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

Early termination was due to changes in the standard of care within the proposed market. The study was designed when patient monitoring and no treatment was an option that will not support a confirmatory Phase 3 study. No safety or efficacy concerns.

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: July 31, 2009
• Primary Completion: October 29, 2012
• Study Completion: October 29, 2012
• Last Updated: November 5, 2020
• Results First Posted: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

FR (4); UA (3); DE (3); IT (5); PL (5); GB (5); ES (3); RU (8); CZ (3)