Metastatic Colorectal CancerPhase 1NCT01124630
Study of CS-1008 in Combination With FOLFIRI in Patients Who Have Failed Other Treatments
A Phase 1 study testing CS-1008 and FOLFIRI in people with Metastatic Colorectal Cancer, run by Daiichi Sankyo at 3 sites in United States.
Trial summary
Treatment with CS-1008 in combination with FOLFIRI (irinotecan, leucovorin, and 5-fluorouracil [5-FU]) in subjects with metastatic colorectal cancer (CRC) who have failed first-line treatment that was not irinotecan-based. 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 FOLFIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Aug 2013
- Phase
- Phase 1
- 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, metastatic CRC that has progressed after first-line standard therapy that was not irinotecan-based.
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2.
- Adequate organ and bone marrow function as evidenced by:
- Hemoglobin >= 9 g/dL
- White blood cell count (WBC) >= 3.0 x 109/L
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- Absolute neutrophil count (ANC) >= 1.5 x 109/L
- Platelet count >= 100 x 109/L
- Serum creatinine < the upper limit of normal (ULN)
- AST and alkaline phosphatase =< 2.5 x ULN if without liver metastasis and =< 5.0 x ULN if liver metastasis
- Total bilirubin =< ULN
- Male and female subjects of reproductive potential must be willing to consent to using effective contraception while on treatment and for 3 months after the end of treatment.
- Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) result within 8 days before starting 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 IRB-approved ICF before performance of any study-specific procedures or tests.
- At study centers located in the US, subjects must also sign a HIPAA authorization.
- KRAS Mutant
Who cannot join
- Anticipation of a 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 6 weeks before study enrollment.
- First-line therapy for CRC that was irinotecan-based.
- History of any of the following conditions within 6 months before study enrollment:
- Myocardial infarction;
- Severe/unstable angina pectoris;
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- Coronary/peripheral artery bypass graft;
- New York Heart Association (NYHA) class III or IV congestive heart failure;
- Cerebrovascular accident or transient ischemic attack;
- Pulmonary embolism or other clinically significant thromboembolic event; or
- Clinically significant pulmonary disease (eg, severe chronic obstructive pulmonary disease or asthma).
- Clinically active brain metastasis (ie, untreated, still requiring therapy with steroids or RT, or with progression within 4 weeks after completion of RT); an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis.
- 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.
- Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV)-positive subjects receiving antiretroviral therapy.
- Previous treatment with CS-1008, other agonistic DRSantibodies, or with TRAIL agonists.
- If female, pregnant or breastfeeding.
- Known history of hypersensitivity reactions to any of the components of CS-1008, irinotecan, leucovorin, or 5-FU 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.
- Must not be known to be homozygous for the UGT1A1*28 allele, as this increases the risk for neutropenia following irinotecan treatment.
- Kras allele status must not be wild type.
- Dihydropyrimidine dehydrogenase (DPD) deficiency.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 86259
About this study
Official title: Pilot Study of CS-1008 in Combination With FOLFIRI (Irinotecan, Leucovorin, and 5-fluorouracil [5-FU]) in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Failed First-line Treatment That Was Not Irinotecan-based.
Treatment with CS-1008 in combination with FOLFIRI (irinotecan, leucovorin, and 5-fluorouracil [5-FU]) in subjects with metastatic colorectal cancer (CRC) who have failed first-line treatment that was not irinotecan-based.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- CS-1008, FOLFIRI
- 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 will be administered IV each week. The initial/loading dose (6 mg/kg) will be administered Day 1 of Cycle 1. Maintenance doses of 2 mg/kg will be administered weekly thereafter.
FOLFIRIDrug
Also called irinotecan, leucovorin, 5-FU, Camptosar
The FOLFIRI regimen will be administered IV at Weeks 1 and 3 of each 4 week cycle, and it will begin at Week 1 of Cycle 1. It will comprise irinotecan, 180 mg/m2 IV infusion over 30 to 120 minutes; leucovorin, 400 mg/m2 IV infusion to match the duration of the irinotecan infusion; and 5-FU, 400 mg/m2 (bolus) followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46 to 48 hours continuous infusion).
| Study group | Role | What they receive |
|---|---|---|
| CS-1008 with FOLFIRI | Experimental | Experimental drug CS-1008 in combination with FOLFIRI Receives: Drug: CS-1008; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To obtain a preliminary assessment of the antitumor activity of CS-1008 in combination with a FOLFIRI regimen based on the Objective Response Rate (ORR)
Measured: up to 6 months
Progression Free Survival
To obtain a preliminary assessment of the antitumor activity of CS-1008 in combination with a FOLFIRI regimen based on the Progression Free Survival (PFS)
Measured: up to 6 months
Secondary outcomes (1)
Serum concentrations
to determine serum concentrations at selected time intervals
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2013
- Study completionAug 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT01124630
- Sponsor's protocol ID
- CS1008-A-U105
- Status last verified
- Dec 2013
- First submitted
- 10 May 2010
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of CS-1008 in Combination With FOLFIRI (Irinotecan, Leucovorin, and 5-fluorouracil [5-FU]) in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Failed First-line Treatment That Was Not Irinotecan-based.
- ClinicalTrials.gov ID
- NCT01124630
- Acronym / sponsor ID
- CS1008-A-U105
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 May 2010 (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.
Treatment with CS-1008 in combination with FOLFIRI (irinotecan, leucovorin, and 5-fluorouracil [5-FU]) in subjects with metastatic colorectal cancer (CRC) who have failed first-line treatment that was not irinotecan-based.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS-1008 with FOLFIRI | Experimental | Drug: CS-1008, Drug: FOLFIRIExperimental drug CS-1008 in combination with FOLFIRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed, metastatic CRC that has progressed after first-line standard therapy that was not irinotecan-based.
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2.
- Adequate organ and bone marrow function as evidenced by:
- Male and female subjects of reproductive potential must be willing to consent to using effective contraception while on treatment and for 3 months after the end of treatment.
Key exclusion criteria (21 listed)
- Anticipation of a 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 6 weeks before study enrollment.
- First-line therapy for CRC that was irinotecan-based.
- History of any of the following conditions within 6 months before study enrollment:
- Clinically active brain metastasis (ie, untreated, still requiring therapy with steroids or RT, or with progression within 4 weeks after completion of RT); an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis.
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 will be administered IV each week. The initial/loading dose (6 mg/kg) will be administered Day 1 of Cycle 1. Maintenance doses of 2 mg/kg will be administered weekly thereafter. | Drug | CS-1008 with FOLFIRI |
| FOLFIRIAlso: irinotecan, leucovorin, 5-FU, CamptosarThe FOLFIRI regimen will be administered IV at Weeks 1 and 3 of each 4 week cycle, and it will begin at Week 1 of Cycle 1. It will comprise irinotecan, 180 mg/m2 IV infusion over 30 to 120 minutes; leucovorin, 400 mg/m2 IV infusion to match the duration of the irinotecan infusion; and 5-FU, 400 mg/m2 (bolus) followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46 to 48 hours continuous infusion). | Drug | CS-1008 with FOLFIRI |
Primary outcome
Objective Response Rate
Time frame: up to 6 months
To obtain a preliminary assessment of the antitumor activity of CS-1008 in combination with a FOLFIRI regimen based on the Objective Response Rate (ORR)
Progression Free Survival
Time frame: up to 6 months
To obtain a preliminary assessment of the antitumor activity of CS-1008 in combination with a FOLFIRI regimen based on the Progression Free Survival (PFS)
1 secondary outcome
Serum concentrations
Time frame: weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
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CRC
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS-1008 and FOLFIRI in people with Metastatic Colorectal Cancer, run by Daiichi Sankyo at 3 sites in United States.
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 16 inclusion and 21 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: finished, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective Response Rate (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 3 Dec 2013.