Colorectal CancerPhase 2NCT01116271
Study of Selumetinib (AZD6244)(ARRY-142886) in Combination With Irinotecan in Previously Treated Patients With Colorec
A Phase 2 study testing AZD6244 and Irinotecan in people with Colorectal Cancer, run by AstraZeneca at 12 sites in United States.
Trial summary
The purpose of this study is to determine whether treatment with Selumetinib (AZD6244) (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or B-raf mutation will prevent tumor progression and prolong progression free survival. 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?
- AZD6244 and Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2010to Jul 2012
- 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
- Histological or cytological confirmation of advanced or metastatic colorectal cancer with available tissue and tumor sample confirmed as K-ras or B-raf mutation positive. Current failure of 1st line anti-cancer therapy with an oxaliplatin and bevacizumab based regimen or patients relapsing within 12 months of completing adjuvant FOLFOX .
Who cannot join
- Treatment within 14 days prior to first study treatment with conventional therapy or treatment within 28 days prior to first study treatment with an investigational drug Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Research Site
Aurora, Colorado
Reserach Site
Chapel Hill, North Carolina
Research Site
Greenville, North Carolina
Research Site
Los Angeles, California
Research Site
Miami Beach, Florida
Research Site
New Haven, Connecticut
Research Site
New York, New York
Research Site
Newark, Delaware
Research Site
Palm Springs, California
Research Site
Philadelphia, Pennsylvania
Research Site
Seattle, Washington
Research Site
Washington, North Carolina
About this study
Official title: A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination With Irinotecan, in 2nd Line Patients With K-ras or B-raf Mutation Positive Advanced or Metastatic Colorectal Cancer
The purpose of this study is to determine whether treatment with Selumetinib (AZD6244) (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or B-raf mutation will prevent tumor progression and prolong progression free survival.
Read the detailed description
A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination with Irinotecan, in 2nd Line Patients with K-ras or B-raf Mutation Positive Advanced or Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Being tested
- AZD6244, Irinotecan
- Keywords
- colorectal, second line therapy, K-ras or B-raf mutations, response rate, Progression Free Survival
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6244Drug
Also called Selumetinib
50 or 75mg, capsules, PO, BID, 28 days
IrinotecanDrug
Also called Camptosar; Campto
180mg/m2, IV, Day 1\& 15 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Selumetinib (AZD6244) in combination with irinotecan Receives: Drug: AZD6244; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol.
Measured: AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment
Objective Response Rate will be assessed by the RECIST guideline documented in the European Journal of Cancer, 2009.
Measured: Tumor evaluation via RECIST guidelines will be done on screening visit, day 22 of every other cycle, and treatment discontinuation visit
Secondary outcomes (3)
Safety of combination of Selumetinib (AZD6244) with irinotecan by SAE and AE documentation
Measured: AEs will be assesed at the screening visit, each cycle visit, treatment discontinuation date, and 30 days post last day of study treatment
PK of Selumetinib (AZD6244), N-desmethyl Selumetinib(AZD6244) and selumetinib (AZD6244) amide in combination with irinotecan
Measured: PK sample draws will take place on Day 1 and 15 of first cycle
Progression Free Survival (PFS) for patients with K-ras or B-raf mutations treated with combination of irinotecan and Selumetinib (AZD6244)
Measured: PFS will be determined via the RECIST guidelines on tumor measurement done on day 22 of every other cycle and on the treatment discontinuation visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Hochster, MD, Principal investigator, Yale UniversityLawrence Leichman, MD, Principal investigator, Desert Regional Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116271
- Sponsor's protocol ID
- D9010C00009
- Other IDs
- AGICC 09CRC02
- Status last verified
- Jan 2013
- First submitted
- 30 Apr 2010
- Last updated
- 14 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination With Irinotecan, in 2nd Line Patients With K-ras or B-raf Mutation Positive Advanced or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01116271
- Acronym / sponsor ID
- D9010C00009
- Conditions
- Colorectal Cancer
- Keywords
- colorectal, second line therapy, K-ras or B-raf mutations, response rate, Progression Free Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 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.
The purpose of this study is to determine whether treatment with Selumetinib (AZD6244) (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or B-raf mutation will prevent tumor progression and prolong progression free survival.
Detailed description
A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination with Irinotecan, in 2nd Line Patients with K-ras or B-raf Mutation Positive Advanced or Metastatic Colorectal Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6244, Drug: IrinotecanSelumetinib (AZD6244) in combination with irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histological or cytological confirmation of advanced or metastatic colorectal cancer with available tissue and tumor sample confirmed as K-ras or B-raf mutation positive. Current failure of 1st line anti-cancer therapy with an oxaliplatin and bevacizumab based regimen or patients relapsing within 12 months of completing adjuvant FOLFOX .
Key exclusion criteria (1 listed)
- Treatment within 14 days prior to first study treatment with conventional therapy or treatment within 28 days prior to first study treatment with an investigational drug Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen
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 |
|---|---|---|
| AZD6244Also: Selumetinib50 or 75mg, capsules, PO, BID, 28 days | Drug | 1 |
| IrinotecanAlso: Camptosar; Campto180mg/m2, IV, Day 1\& 15 of each cycle | Drug | 1 |
Primary outcome
Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol.
Time frame: AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment
Objective Response Rate will be assessed by the RECIST guideline documented in the European Journal of Cancer, 2009.
Time frame: Tumor evaluation via RECIST guidelines will be done on screening visit, day 22 of every other cycle, and treatment discontinuation visit
3 secondary outcomes
Safety of combination of Selumetinib (AZD6244) with irinotecan by SAE and AE documentation
Time frame: AEs will be assesed at the screening visit, each cycle visit, treatment discontinuation date, and 30 days post last day of study treatment
PK of Selumetinib (AZD6244), N-desmethyl Selumetinib(AZD6244) and selumetinib (AZD6244) amide in combination with irinotecan
Time frame: PK sample draws will take place on Day 1 and 15 of first cycle
Progression Free Survival (PFS) for patients with K-ras or B-raf mutations treated with combination of irinotecan and Selumetinib (AZD6244)
Time frame: PFS will be determined via the RECIST guidelines on tumor measurement done on day 22 of every other cycle and on the treatment discontinuation visit
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 14 Jan 2013.
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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.
Howard Hochster, MD principal investigator
Yale University
Lawrence Leichman, MD principal investigator
Desert Regional Comprehensive Cancer Center
12 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 AZD6244 and Irinotecan in people with Colorectal Cancer, run by AstraZeneca 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 1 inclusion and 1 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 14 Jan 2013. 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 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 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?
Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol. (time frame: AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment). 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 14 Jan 2013.