CS-1008 Used With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Treatment With Oxaliplatin

January 30, 2012 updated by: Daiichi Sankyo, Inc.

A Phase 2 Open-label Randomized, Controlled Trial of CS-1008 in Combination With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Oxaliplatin Based Regimen

The purpose of this study is to determine the effect of CS-1008 in combination with irinotecan compared to irinotecan alone on Progression-Free Survival (PFS) in subjects with metastatic or advanced colorectal cancer (CRC) who have failed oxaliplatin-based first-line treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital Bath
      • Dudley, United Kingdom, DY1 2HQ
        • Russels Hall Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Broomfield Hospital
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
    • Notts
      • Nottingham, Notts, United Kingdom, NG5 1PB
        • Nottingham City Hospital
    • Oxon
      • Oxford, Oxon, United Kingdom, OX37LJ
        • Chrichill Hospital
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
    • Wirral
      • Bebington, Wirral, United Kingdom, CH634JY
        • Clatterbridge Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed CRC which is now metastatic and after failure of oxaliplatin-based first-line treatment.
  • At least 18 years of age.
  • ECOG performance status =< 1.
  • Measurable disease based on RECIST criteria.

  • Adequate organ and bone marrow function as evidenced by:

    • Hemoglobin >= 9.0 g/dL (may be transfused to this level)
    • Absolute neutrophil count (ANC) >= 1.5 x 109/L
    • Platelet count >= 100 x 109/L
    • Serum creatinine =< upper limit of normal (ULN) or creatinine clearance > 50 mL/min
    • AST <= 2.5 x ULN in subjects with no liver metastasis and <= 5.0 x ULN in subjects with liver metastasis
    • Total bilirubin < 1.5 x ULN
  • Men and women of childbearing potential must be willing to consent to using effective contraception (e.g., hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for 3 months thereafter.
  • All female subjects of childbearing potential must have a negative pregnancy test (serum or urine) result within 7 days 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/IRB approved ICF before performance of any study specific procedures or tests.
  • Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study.
  • Treatment with chemotherapy hormonal therapy, RT, minor surgery, or any investigational agent within 4 weeks before study enrollment. Treatment with nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery within six weeks prior to study enrollment. St John's Wort within 2 weeks prior to study enrollment or during the study.

  • History of any of the following conditions within 6 months before study enrollment:

    • Clinically significant myocardial infarction or severe/unstable angina pectoris
    • New York Heart Association (NYHA) class III or IV congestive heart failure (Section 17.2)
    • Clinically significant cerebrovascular accident, transient ischemic attack or pulmonary embolism- Clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease or asthma)
  • Presence of any of the following: Symptomatic brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis.
  • Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy.
  • History of malignancy other than CRC, unless there is the expectation that the malignancy has been cured, and tumor specific treatment for the malignancy has not been administered within the previous 5 years. Exceptions to this are non melanotic cancer of the skin and adequately treated carcinoma of the cervix-in-situ.
  • Previous treatment with CS 1008, other agonistic DR5 antibody agents, or TRAIL agents.
  • History of active chronic inflammatory bowel disease and/or bowel obstruction within the last 3 months.
  • Pregnant or breast feeding.
  • Known history of hypersensitivity reactions to irinotecan or to one of the excipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CS-1008 with irinotecan
CS-1008 and irinotecan
Drug: CS-1008
CS-1008
Drug: irinotecan
irinotecan
Other Names:
  • Camptosar
Active Comparator: irintoecan
irinotecan alone
Drug: irinotecan
irinotecan
Other Names:
  • Camptosar

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Determine the difference in overall survival for CS-1008 administered in combination with irinotecan and irinotecan alone.
Time Frame: 1 year
1 year
Determine the difference in median survival for CS-1008 administered in combination with irinotecan and irinotecan alone.
Time Frame: 1 year
1 year
Determine the difference in objective response rate (ORR) for CS-1008 administered in combination with irinotecan and irinotecan alone.
Time Frame: 1 year
1 year
To determine the Incidence of anti- CS-1008 antibody formation.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS1008-A-E203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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