Metastatic Colorectal CancerPhase 2NCT00969033
CS-1008 Used With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Treatment With Oxaliplatin
A Phase 2 study testing CS-1008 and irinotecan in people with Metastatic Colorectal Cancer, run by Daiichi Sankyo at 9 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- CS-1008 and irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Jul 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Royal United Hospital Bath
Bath, BA1 3NG
Clatterbridge Hospital
Bebington, Wirral, CH634JY
Broomfield Hospital
Chelmsford, Essex, CM1 7ET
Russels Hall Hospital
Dudley, DY1 2HQ
Leicester Royal Infirmary
Leicester, LE1 5WW
Mount Vernon Hospital
Northwood, Middlesex, HA6 2RN
Nottingham City Hospital
Nottingham, Notts, NG5 1PB
Chrichill Hospital
Oxford, Oxon, OX37LJ
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- CS-1008, irinotecan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-1008Drug
CS-1008
irinotecanDrug
Also called Camptosar
irinotecan
| Study group | Role | What they receive |
|---|---|---|
| CS-1008 with irinotecan | Experimental | CS-1008 and irinotecan Receives: Drug: CS-1008; Drug: irinotecan |
| irintoecan | Active comparator | irinotecan alone Receives: Drug: irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone.
Measured: 1 year
Secondary outcomes (4)
Determine the difference in overall survival for CS-1008 administered in combination with irinotecan and irinotecan alone.
Measured: 1 year
Determine the difference in median survival for CS-1008 administered in combination with irinotecan and irinotecan alone.
Measured: 1 year
Determine the difference in objective response rate (ORR) for CS-1008 administered in combination with irinotecan and irinotecan alone.
Measured: 1 year
To determine the Incidence of anti- CS-1008 antibody formation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969033
- Sponsor's protocol ID
- CS1008-A-E203
- Status last verified
- Jan 2012
- First submitted
- 28 Aug 2009
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00969033
- Acronym / sponsor ID
- CS1008-A-E203
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS-1008 with irinotecan | Experimental | Drug: CS-1008, Drug: irinotecanCS-1008 and irinotecan |
| irintoecan | Active comparator | Drug: irinotecanirinotecan alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (13 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS-1008CS-1008 | Drug | CS-1008 with irinotecan |
| irinotecanAlso: Camptosaririnotecan | Drug | CS-1008 with irinotecan, irintoecan |
Primary outcome
Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone.
Time frame: 1 year
4 secondary outcomes
Determine the difference in overall survival for CS-1008 administered in combination with irinotecan and irinotecan alone.
Time frame: 1 year
Determine the difference in median survival for CS-1008 administered in combination with irinotecan and irinotecan alone.
Time frame: 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
To determine the Incidence of anti- CS-1008 antibody formation.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CS-1008 and irinotecan in people with Metastatic Colorectal Cancer, run by Daiichi Sankyo at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.