Colorectal CancerPhase 1/2NCT00838578

Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

A Phase 1/2 study testing KRN330 and Irinotecan in people with Colorectal Cancer, run by Kyowa Kirin Co., Ltd. at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: KRN330 and Irinotecan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 12 sitesUnited States
Study dates: Mar 2009to Oct 2012
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible.
At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
At least 4 weeks have elapsed since any major surgery.
Have ECOG performance status of 0, 1, or 2.
Have adequate bone marrow and organ function

Who cannot join

Have an active, uncontrolled infection.
Have known HIV positive status.
Have known or suspected cerebral metastasis.
Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
Have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).
Have a history of greater than or equal to Grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies).
Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Florida Cancer Specialists
Fort Myers, Florida, 33916
University of Florida COllege of Medicine/Shands Cancer Center
Gainesville, Florida, 32610
Clearview Cancer Institute
Huntsville, Alabama, 35805
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Clinical Trials Office, New York University Cancer Institute
New York, New York, 10016
Arizona Clinical Research Center
Tucson, Arizona, 85715
Lombardi Comprehensive Cancer Center, Georgetown University Hospital
Washington D.C., District of Columbia, 20007-2113

Other trials in United States

About this study

Official title: Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer

Read the detailed description

Phase II portion is an open-label, single arm study. Based on the results of the Phase I portion, weekly KRN330 (0.5 mg/kg) and biweekly irinotecan (180 mg/m2) will be used in the Phase II portion. To be eligible for the Phase II portion, a patient will have recurred or progressed within 6 months of the last cycle of FOLFOX/CapOx +/- bevacizumab (first-line or adjuvant regimen for metastatic colorectal cancer). Patients will continue the treatment until disease progression.

Per protocol, the decision was made to terminate the study based on interim analysis results. The Response Rate in Phase II did not meet the protocol-specified RR of 15% when 0.5 mg/kg KRN330 was administered weekly in combination with irinotecan(180 mg/m2)biweekly.

Conditions: Colorectal Cancer
Being tested: KRN330, Irinotecan
Keywords: KRN330, Colorectal Cancer, Antimetabolites, Antimetabolites, Antineoplastic, Digestive System Neoplasms, Immunologic Factors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Gastrointestinal Diseases, Physiological Effects of Drugs, Colonic Diseases, Irinotecan, Enzyme Inhibitors, Intestinal Diseases, Immunosuppressive Agents, Rectal Diseases, Pharmacologic Actions, Intestinal Neoplasms, Neoplasms by Site, Digestive System Diseases
Medical subject headings: Colorectal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases, Intestinal Neoplasms, Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KRN330Biological
KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.
IrinotecanDrug
Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.

Study groups in NCT00838578
Study group	Role	What they receive
KRN330 + Irinotecan	Experimental	open label, single arm Receives: Biological: KRN330; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0
Measured: Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Oct 2012

First posted6 Feb 2009 (estimated)
Study startMar 2009
Primary completionJul 2012
Study completionOct 2012

Why it stopped: Per protocol, the study was terminated based on interim analysis results

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Kyowa Kirin Co., Ltd.The 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00838578
Sponsor's protocol ID: KRN330-US-02
Status last verified: Apr 2024
First submitted: 4 Feb 2009
Last updated: 26 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT00838578
Acronym / sponsor ID: KRN330-US-02
Conditions: Colorectal Cancer
Keywords: KRN330, Colorectal Cancer, Antimetabolites, Antimetabolites, Antineoplastic, Digestive System Neoplasms, Immunologic Factors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Per protocol, the study was terminated based on interim analysis results
Enrolment: 65 participants (actual)
Lead sponsor: Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Kyowa Hakko Kirin Pharma, Inc.
Study start: Mar 2009
Primary completion: Jul 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 6 Feb 2009 (estimated)
Results: Posted 23 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
KRN330 + Irinotecan	Experimental	Biological: KRN330, Drug: Irinotecanopen label, single arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible.
At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
At least 4 weeks have elapsed since any major surgery.

Key exclusion criteria (7 listed)

Have an active, uncontrolled infection.
Have known HIV positive status.
Have known or suspected cerebral metastasis.
Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
Have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).

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
KRN330KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.	Biological	KRN330 + Irinotecan
IrinotecanIrinotecan will be dosed at 180 mg/m2 biweekly until disease progression.	Drug	KRN330 + Irinotecan

Primary outcome

Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0
Time frame: Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months

Results and safety

Results posted to the registry on 23 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KRN330 + Irinotecan	65	63

Primary outcome: Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0

Time frame: Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months. Number. Unit: participants

Measure	Regimen A: KRN330 Biweekly + Irinotecan Biweekly n = 12	Regimen B: KRN330 Weekly + Irinotecan Biweekly n = 7	PH 2 Treatment: KRN330 Wkly + IRI Biwkly n = 44
Value	12	7	44

Population analysed: ITT population

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly	6 of 12 (50%)	12 of 12 (100%)	Not reported
Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly	2 of 7 (28.6%)	7 of 7 (100%)	Not reported
Phase 2: KRN330 Weekly + IRI Biweekly	17 of 44 (38.6%)	42 of 44 (95.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Michael Kurman, MD study director

Kyowa Hakko Kirin Pharma, Inc.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KRN330 and Irinotecan in people with Colorectal Cancer, run by Kyowa Kirin Co., Ltd. at 12 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 7 inclusion and 7 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0 (time frame: Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00838578.

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 26 Apr 2024.