Metastatic Colorectal CancerPhase 1/2NCT00494221
A Phase I/II Study of Cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX
A Phase 1/2 study testing AZD2171 and FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) in people with Metastatic Colorectal Cancer, run by AstraZeneca at 2 sites in Japan.
Trial summary
This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. 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?
- AZD2171 and FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 2 sitesJapan
- Study dates
- Jun 2007to Aug 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
- Metastatic colorectal cancer
- WHO performance status 0-1
- Life expectancy is 12 weeks or longer
Who cannot join
- Patient with uncontrolled brain metastases
- Patient with inappropriate laboratory tests values
- Patient with poorly controlled hypertension
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-label Phase I Part to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With FOLFOX Followed by a Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib (AZD2171) in Combination With FOLFOX
This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. Once this part is complete and it is decided that it is safe to continue the Study will the go on to look at the efficacy of the two drugs together. This will be done by studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that non-one can tell the difference between the two treatment groups. This kind of study design is done to try to avoid the chance that the results might be biased in some way. The overall aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results. That is, it's better than giving standard treatment alone in helping to prevent progression of mCRC.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- AZD2171, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), Placebo Cediranib
- Keywords
- Colorectal cancer, Recentin, Metastatic Cancer, FOLFOX
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2171Drug
Also called cediranib, RECENTIN™
oral tablet
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)Drug
Also called Eloxatin®, 5-FU, Leucovorin
intravenous infusion
Placebo CediranibDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX + Cediranib 20 mg | Active comparator | FOLFOX + Cediranib 20 mg Receives: Drug: AZD2171; Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) |
| FOLFOX + Cediranib 30 mg | Active comparator | FOLFOX + Cediranib 30 mg Receives: Drug: AZD2171; Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) |
| FOLFOX + Placebo Cediranib | Placebo comparator | FOLFOX + Placebo Cediranib Receives: Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin); Drug: Placebo Cediranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Measured: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)
Secondary outcomes (4)
Objective Tumour Response Rate
Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.
Measured: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)
Best Percentage Change in Tumour Size
Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions
Measured: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)
Duration of Response
Number of months from Complete/Partial response until progression up to cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups).
Measured: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)
Overall Survival
Number of months until death (censored if still alive at date cut-off). Median non-estimable if >50% of subjects within a group are censored.
Measured: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2009
- Study completionAug 2012
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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jane Robertson, Study director, AstraZenecaHideyuki Mishima, M.D., PhD, Principal investigator, National Hospital Organization Osaka National HospitalXiaojin Shi, MD, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494221
- Sponsor's protocol ID
- D8480C00039
- Status last verified
- Feb 2014
- First submitted
- 27 Jun 2007
- Last updated
- 27 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-label Phase I Part to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With FOLFOX Followed by a Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib (AZD2171) in Combination With FOLFOX
- ClinicalTrials.gov ID
- NCT00494221
- Acronym / sponsor ID
- D8480C00039
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal cancer, Recentin, Metastatic Cancer, FOLFOX
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Posted 5 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. Once this part is complete and it is decided that it is safe to continue the Study will the go on to look at the efficacy of the two drugs together. This will be done by studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that non-one can tell the difference between the two treatment groups. This kind of study design is done to try to avoid the chance that the results might be biased in some way. The overall aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results. That is, it's better than giving standard treatment alone in helping to prevent progression of mCRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FOLFOX + Cediranib 20 mg | Active comparator | Drug: AZD2171, Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)FOLFOX + Cediranib 20 mg |
| FOLFOX + Cediranib 30 mg | Active comparator | Drug: AZD2171, Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)FOLFOX + Cediranib 30 mg |
| FOLFOX + Placebo Cediranib | Placebo comparator | Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), Drug: Placebo CediranibFOLFOX + Placebo Cediranib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Metastatic colorectal cancer
- WHO performance status 0-1
- Life expectancy is 12 weeks or longer
Key exclusion criteria (3 listed)
- Patient with uncontrolled brain metastases
- Patient with inappropriate laboratory tests values
- Patient with poorly controlled hypertension
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 |
|---|---|---|
| AZD2171Also: cediranib, RECENTIN™oral tablet | Drug | FOLFOX + Cediranib 20 mg, FOLFOX + Cediranib 30 mg |
| FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)Also: Eloxatin®, 5-FU, Leucovorinintravenous infusion | Drug | FOLFOX + Cediranib 20 mg, FOLFOX + Cediranib 30 mg, FOLFOX + Placebo Cediranib |
| Placebo Cediraniboral tablet | Drug | FOLFOX + Placebo Cediranib |
Primary outcome
Progression Free Survival
Time frame: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)
Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
4 secondary outcomes
Objective Tumour Response Rate
Time frame: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)
Best Percentage Change in Tumour Size
Time frame: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)
Duration of Response
Time frame: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)
Overall Survival
Time frame: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CSR-D8480C00039.pdfLink provided by the sponsor.
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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.
Jane Robertson study director
AstraZeneca
Hideyuki Mishima, M.D., PhD principal investigator
National Hospital Organization Osaka National Hospital
Xiaojin Shi, MD study chair
AstraZeneca
2 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 AZD2171 and FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) in people with Metastatic Colorectal Cancer, run by AstraZeneca at 2 sites in Japan.
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 3 inclusion and 3 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 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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. Some participants in this study may receive a placebo. 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 5 Jun 2012). 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?
Progression Free Survival (time frame: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)). 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 27 Mar 2014.