Colorectal CancerPhase 1NCT00671372
A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer
A Phase 1 study testing FOLFIRI regimen, bevacizumab and cetuximab in people with Colorectal Cancer, run by Genentech, Inc. at 10 sites in United States.
Trial summary
This study will assess the safety and pharmacokinetics of adding dulanermin to Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy). 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?
- FOLFIRI regimen, bevacizumab and cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2006to Mar 2012
- 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
- Signed Informed Consent Form
- Age >= 18 years
- Histologically confirmed CRC with evidence of metastases and measurable tumor lesion(s)
- Progression of disease following, or intolerance to, treatment with 5-fluorouracil-based therapy
- Progression of disease during or within =< 6 months following the last dose of a prior first-line treatment with a fluoropyrimidine and oxaliplatin-based chemotherapy plus bevacizumab for metastatic disease
- Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential (use per institutional standard)
- Life expectancy of > 3 months
- Willingness and capability to be accessible for study follow-up
Who cannot join
- Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response
- Radiation therapy to a peripheral lesion within 14 days prior to Day 1; Radiation therapy to a thoracic, abdominal or pelvic field within 28 days prior to Day 1
- Chemotherapy, hormonal therapy, or immunology within 4 weeks prior to Day 1
- Previous exposure to DR4-targeted therapy or DR5-targeted therapy
- Evidence of clinically detectable ascites on Day
- Other invasive malignancies within 5 years prior to Day 1 (other than basal cell carcinoma of the skin or in situ carcinoma of the cervix)
Show all 16Show fewer
- History or evidence upon physical examination of CNS disease
- Active infection requiring parenteral antibiotics on Day 1
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study and fine needle aspirations within 7 days prior to Day 1
- Pregnancy or lactation
- Serious nonhealing wound, ulcer, or bone fracture
- Current or recent participation in another experimental drug study
- Clinically significant cardiovascular disease
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
- Cohort 5 only: Subjects who have a Kras mutation will be excluded from enrollment
- The following exclusion criteria apply only to subjects who have received prior bevacizumab and are enrolled in Cohort 6: four or more prior doses of bevacizumab therapy, inadequately controlled hypertension, history of hypertensive crisis or hypertensive encephalopathy, history of arterial thromboembolic event 6 months prior to Day 1, proteinuria, history of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Buffalo, New York, 14263
Study site
Durham, North Carolina, 27710
Study site
Fort Myers, Florida, 33916
Study site
Harvey, Illinois, 60426
Study site
Hershey, Pennsylvania, 17033
Study site
Los Angeles, California, 90095
Study site
Nashville, Tennessee, 37203
Study site
Redlands, California, 92374
Study site
San Francisco, California, 94115
Study site
Tacoma, Washington, 98405
About this study
Official title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Multiple Doses of Dulanermin Administered Intravenously in Combination With Camptosar®/Erbitux® Chemotherapy or the Folfiri Regimen With or Without Bevacizumab in Subjects With Previously Treated Metastatic Colorectal Cancer
This study will assess the safety and pharmacokinetics of adding dulanermin to Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy).
- Conditions
- Colorectal Cancer
- Being tested
- FOLFIRI regimen, bevacizumab, cetuximab, dulanermin, irinotecan
- Keywords
- CRC, Metastatic CRC, APO2L/TRAIL
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRI regimenDrug
Intravenous repeating dose
bevacizumabDrug
Intravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)
cetuximabDrug
Intravenous repeating dose
dulanerminDrug
Intravenous repeating dose
irinotecanDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| Cohorts 1-5 | Experimental | Not described Receives: Drug: cetuximab; Drug: dulanermin; Drug: irinotecan |
| Cohorts 6, 6A, 7, 7A | Experimental | Not described Receives: Drug: FOLFIRI regimen; Drug: bevacizumab; Drug: dulanermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of dulanermin administered in combination with Camptosar and Erbitux
Measured: Length of study
The safety and tolerability of dulanermin administered in combination with FOLFIRI (with or without Bevacizumab)
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startJul 2006
- Primary completionMar 2012
- Study completionMar 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 Genentech, Inc.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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia Portera, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671372
- Sponsor's protocol ID
- APO3583g
- Other IDs
- GO00933
- Status last verified
- Nov 2016
- First submitted
- 18 Apr 2008
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Multiple Doses of Dulanermin Administered Intravenously in Combination With Camptosar®/Erbitux® Chemotherapy or the Folfiri Regimen With or Without Bevacizumab in Subjects With Previously Treated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00671372
- Acronym / sponsor ID
- APO3583g
- Conditions
- Colorectal Cancer
- Keywords
- CRC, Metastatic CRC, APO2L/TRAIL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 May 2008 (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 and pharmacokinetics of adding dulanermin to Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohorts 1-5 | Experimental | Drug: cetuximab, Drug: dulanermin, Drug: irinotecan |
| Cohorts 6, 6A, 7, 7A | Experimental | Drug: FOLFIRI regimen, Drug: bevacizumab, Drug: dulanermin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent Form
- Age >= 18 years
- Histologically confirmed CRC with evidence of metastases and measurable tumor lesion(s)
- Progression of disease following, or intolerance to, treatment with 5-fluorouracil-based therapy
- Progression of disease during or within =< 6 months following the last dose of a prior first-line treatment with a fluoropyrimidine and oxaliplatin-based chemotherapy plus bevacizumab for metastatic disease
Key exclusion criteria (16 listed)
- Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response
- Radiation therapy to a peripheral lesion within 14 days prior to Day 1; Radiation therapy to a thoracic, abdominal or pelvic field within 28 days prior to Day 1
- Chemotherapy, hormonal therapy, or immunology within 4 weeks prior to Day 1
- Previous exposure to DR4-targeted therapy or DR5-targeted therapy
- Evidence of clinically detectable ascites on Day
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 |
|---|---|---|
| FOLFIRI regimenIntravenous repeating dose | Drug | Cohorts 6, 6A, 7, 7A |
| bevacizumabIntravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab) | Drug | Cohorts 6, 6A, 7, 7A |
| cetuximabIntravenous repeating dose | Drug | Cohorts 1-5 |
| dulanerminIntravenous repeating dose | Drug | Cohorts 1-5, Cohorts 6, 6A, 7, 7A |
| irinotecanIntravenous repeating dose | Drug | Cohorts 1-5 |
Primary outcome
The safety and tolerability of dulanermin administered in combination with Camptosar and Erbitux
Time frame: Length of study
The safety and tolerability of dulanermin administered in combination with FOLFIRI (with or without Bevacizumab)
Time frame: Length of study
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 2016.
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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.
Chia Portera, M.D. study director
Genentech, Inc.
10 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 FOLFIRI regimen, bevacizumab and cetuximab in people with Colorectal Cancer, run by Genentech, Inc. at 10 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 8 inclusion and 16 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 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The safety and tolerability of dulanermin administered in combination with Camptosar and Erbitux (time frame: Length of study). 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 2 Nov 2016.