Colorectal CancerPhase 1NCT00478634
A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer
A Phase 1 study testing RAD001, Cetuximab, Irinotecan in people with Colorectal Cancer and Colorectal Carcinoma, run by Novartis Pharmaceuticals at 16 sites in United States.
Trial summary
This study will assess the safety of RAD001 when given together with cetuximab and irinotecan Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors
- What is being tested?
- RAD001, Cetuximab, 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
- 19 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2007to Sep 2009
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old and ≤ 65 years old.
- Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor.
- Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevacizumab or XELOX (capecitabine and oxaliplatin) plus bevacizumab.
- Patients with at least one measurable lesion by RECIST as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI) or physical examination.
- Patients with a WHO performance status of 0 or 1.
Who cannot join
- Patients with Gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
- Patients who are homozygous for the UGT1A1*28 allele as determined by sequencing.
- Patients who have received previous irinotecan-based therapy.
- Prior treatment with an mTOR inhibitor.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Arlington Cancer Center
Arlington, Texas, 76012
Comprehensive nBlood and Cancer Care
Bakersfield, California, 93309
Oncology/Hematology Associates
Bethlehem, Pennsylvania, 18017
Roswell Park Cancer Institute
Buffalo, New York, 14263
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Highlands Oncology Group
Fayetteville, Arkansas, 72701
UCSD - Moores Cancer Center
La Jolla, California, 92037
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Comprehensive Cancer Care
Los Angeles, California, 90095
North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center
Northridge, California, 91325
Norwalk Hospital
Norwalk, Connecticut, 06850
Oncology Specialists
Park Ridge, Illinois, 60068
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277
Richmond University Medical Center
Staten Island, New York, 10310
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Gerogetown University Lombardi Cancer Center
Washington D.C., District of Columbia, 20057
About this study
Official title: An Open-label, Multicenter Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab (if Given as Part of Local Standard Practice) in Patient With Metastatic Colorectal Adenocarcinoma
This study will assess the safety of RAD001 when given together with cetuximab and irinotecan
- Being tested
- RAD001, Cetuximab, Irinotecan
- Keywords
- Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001, Cetuximab, IrinotecanDrug
| Study group | Role | What they receive |
|---|---|---|
| A1: RAD001 + cetuximab + irinotecan | Experimental | RAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v. Receives: Drug: RAD001, Cetuximab, Irinotecan |
| B1 dose: RAD001 + cetuximab + irinotecan | Experimental | RAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v. Receives: Drug: RAD001, Cetuximab, Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
each cycle was 21 days
Measured: at end of cycle 2
Secondary outcomes (4)
Pharmacokinetics of RAD001, Irinotecan and SN-38
Progressions Free Survival
Overall Survival
Objective Response Rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2009
- Study completionSep 2009
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 Novartis PharmaceuticalsThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478634
- Sponsor's protocol ID
- CRAD001C2242
- Status last verified
- Nov 2012
- First submitted
- 24 May 2007
- Last updated
- 2 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab (if Given as Part of Local Standard Practice) in Patient With Metastatic Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00478634
- Acronym / sponsor ID
- CRAD001C2242
- Keywords
- Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 May 2007 (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.
This study will assess the safety of RAD001 when given together with cetuximab and irinotecan
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1: RAD001 + cetuximab + irinotecan | Experimental | Drug: RAD001, Cetuximab, IrinotecanRAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v. |
| B1 dose: RAD001 + cetuximab + irinotecan | Experimental | Drug: RAD001, Cetuximab, IrinotecanRAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old and ≤ 65 years old.
- Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor.
- Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevacizumab or XELOX (capecitabine and oxaliplatin) plus bevacizumab.
- Patients with at least one measurable lesion by RECIST as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI) or physical examination.
- Patients with a WHO performance status of 0 or 1.
Key exclusion criteria (5 listed)
- Patients with Gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
- Patients who are homozygous for the UGT1A1*28 allele as determined by sequencing.
- Patients who have received previous irinotecan-based therapy.
- Prior treatment with an mTOR inhibitor.
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| RAD001, Cetuximab, Irinotecan | Drug | A1: RAD001 + cetuximab + irinotecan, B1 dose: RAD001 + cetuximab + irinotecan |
Primary outcome
Dose Limiting Toxicities
Time frame: at end of cycle 2
each cycle was 21 days
4 secondary outcomes
Pharmacokinetics of RAD001, Irinotecan and SN-38
Progressions Free Survival
Overall Survival
Objective Response Rate
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 2 Nov 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
16 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 RAD001, Cetuximab, Irinotecan in people with Colorectal Cancer and Colorectal Carcinoma, run by Novartis Pharmaceuticals at 16 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 5 inclusion and 5 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 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Dose Limiting Toxicities (time frame: at end of cycle 2). 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 2 Nov 2012.