Metastatic Colorectal CancerPhase 1NCT00873756
A Study of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
A Phase 1 study testing FOLFOX regimen, bevacizumab and dulanermin in people with Metastatic Colorectal Cancer, run by Genentech, Inc. at 7 sites in United States.
Trial summary
This is a multicenter, open-label study enrolling a total of up to 23 patients. 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?
- FOLFOX regimen, bevacizumab and dulanermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2009to Apr 2014
- 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
- Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease (i.e., by radiographic imaging or biopsy) and measurable tumor lesions
- Life expectancy > 3 months
- For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial
- Willingness and capability to be accessible for study follow-up
Who cannot join
- Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment =< 6 weeks in the advanced or metastatic setting; prior treatment with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred > 6 months from concluding adjuvant therapy
- Peripheral neuropathy Grade >= 2
- Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
- Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1
- Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day 1
- Evidence of clinically detectable ascites
Show all 21Show fewer
- Other invasive malignancies within 5 years prior to Cycle 1, Day 1
- Current or recent participation in another experimental drug study
- Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia within 1 year prior to Cycle 1, Day 1, or Grade II or greater peripheral vascular disease on Cycle 1, Day 1
- Active infection requiring parenteral antibiotics
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle 1, Day 1, fine needle aspirations or minor surgery (such as port placement) within 7 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study
- Known or suspected to be positive for the human immunodeficiency virus (HIV)
- Known to be positive for hepatitis C or hepatitis B surface antigen
- 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 specified study treatment, or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- History of arterial thromboembolic event 6 months prior to Cycle 1, Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Cycle 1, Day 1
- Bleeding diathesis or coagulopathy
- Pregnancy (positive pregnancy test) or breast feeding
- Serious, non-healing wound, ulcer, or bone fracture
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Aurora, Colorado, 80045
Study site
Chapel Hill, North Carolina, 27599
Study site
Fort Collins, Colorado, 80528
Study site
Harvey, Illinois, 60426
Study site
Los Angeles, California, 90095
Study site
San Francisco, California, 94115
About this study
Official title: A Phase Ib Study of the Safety and Pharmacokinetics of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
This is a multicenter, open-label study enrolling a total of up to 23 patients.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFOX regimen, bevacizumab, dulanermin
- Keywords
- CRC, Colon Cancer, Avastin, Apo2L/TRAIL
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
Intravenous repeating dose
bevacizumabDrug
Intravenous repeating dose
dulanerminDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: FOLFOX regimen; Drug: bevacizumab; Drug: dulanermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of dose-limiting toxicities
Measured: Until study discontinuation or the end of Cycle 26
Secondary outcomes (4)
Incidence, nature, and severity of adverse events
Measured: Until study discontinuation or the end of Cycle 26
Change in vital signs
Measured: Until study discontinuation or the end of Cycle 26
Change in clinical laboratory results
Measured: Until study discontinuation or the end of Cycle 26
Incidence of anti-dulanermin antibodies
Measured: Until study discontinuation or the end of Cycle 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT00873756
- Sponsor's protocol ID
- APO4565g
- Other IDs
- GO00934
- Status last verified
- Nov 2016
- First submitted
- 5 Mar 2009
- 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 Study of the Safety and Pharmacokinetics of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00873756
- Acronym / sponsor ID
- APO4565g
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- CRC, Colon Cancer, Avastin, Apo2L/TRAIL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Apr 2009 (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 is a multicenter, open-label study enrolling a total of up to 23 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: FOLFOX 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 (4 listed)
- Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease (i.e., by radiographic imaging or biopsy) and measurable tumor lesions
- Life expectancy > 3 months
- For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial
- Willingness and capability to be accessible for study follow-up
Key exclusion criteria (21 listed)
- Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment =< 6 weeks in the advanced or metastatic setting; prior treatment with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred > 6 months from concluding adjuvant therapy
- Peripheral neuropathy Grade >= 2
- Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
- Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1
- Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day 1
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 |
|---|---|---|
| FOLFOX regimenIntravenous repeating dose | Drug | A |
| bevacizumabIntravenous repeating dose | Drug | A |
| dulanerminIntravenous repeating dose | Drug | A |
Primary outcome
Incidence and nature of dose-limiting toxicities
Time frame: Until study discontinuation or the end of Cycle 26
4 secondary outcomes
Incidence, nature, and severity of adverse events
Time frame: Until study discontinuation or the end of Cycle 26
Change in vital signs
Time frame: Until study discontinuation or the end of Cycle 26
Change in clinical laboratory results
Time frame: Until study discontinuation or the end of Cycle 26
Incidence of anti-dulanermin antibodies
Time frame: Until study discontinuation or the end of Cycle 26
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.
7 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 FOLFOX regimen, bevacizumab and dulanermin in people with Metastatic Colorectal Cancer, run by Genentech, Inc. at 7 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 4 inclusion and 21 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 7 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?
Incidence and nature of dose-limiting toxicities (time frame: Until study discontinuation or the end of Cycle 26). 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.