Colorectal CancerPhase 1NCT00497497
A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)
A Phase 1 study testing bevacizumab, cetuximab and FOLFIRI regimen in people with Colorectal Cancer, run by Genentech, Inc..
Trial summary
This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with… 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?
- bevacizumab, cetuximab and FOLFIRI regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Sep 2010
- 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
- Age ≥ 18 years
- Histologically confirmed CRC with evidence of metastases and measurable tumor lesions
- Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy
- Life expectancy > 3 months
- For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 6 months following their final exposure to study treatment
- Willingness and capability to be accessible for study follow-up
Who cannot join
- Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens
- Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
- Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field
- Recent chemotherapy, hormonal therapy, or immunotherapy
- Evidence of clinically detectable ascites
- Other invasive malignancies within 5 years
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- History or evidence of active central nervous system (CNS) disease
- Current or recent participation in another experimental drug study
- Clinically significant cardiovascular disease
- Active infection requiring parenteral antibiotics
- Recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, 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
- Pregnancy (positive pregnancy test) or breast feeding
- Serious, non-healing wound, ulcer, or bone fracture
- Known sensitivity to any of the products administered during the study
- Any disorder that compromises the ability of the patient to provide written informed consent and/or comply with study procedures
About this study
Official title: A Phase Ib, Dose-Escalation Study of the Safety and Pharmacokinetics of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer
This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.
- Conditions
- Colorectal Cancer
- Being tested
- bevacizumab, cetuximab, FOLFIRI regimen, irinotecan, PRO95780
- Keywords
- CRC, Colon cancer, Avastin, APM4187g
- 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.
bevacizumabDrug
(Only for patients not previously treated with bevacizumab) Intravenous repeating dose
cetuximabDrug
Intravenous repeating dose
FOLFIRI regimenDrug
Intravenous repeating dose
irinotecanDrug
Intravenous repeating dose
PRO95780Drug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: cetuximab; Drug: irinotecan; Drug: PRO95780 |
| 2 | Experimental | Not described Receives: Drug: bevacizumab; Drug: FOLFIRI regimen; Drug: PRO95780 |
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: Through study completion or early study discontinuation
Secondary outcomes (3)
Incidence, nature, and severity of adverse events
Measured: Through study completion or early study discontinuation
Change in vital signs
Measured: Through study completion or early study discontinuation
Incidence and severity of infusion reactions
Measured: Through study completion or early study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2010
- Study completionSep 2010
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gordon Bray, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497497
- Sponsor's protocol ID
- APM4187g
- Status last verified
- May 2017
- First submitted
- 3 Jul 2007
- Last updated
- 19 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Dose-Escalation Study of the Safety and Pharmacokinetics of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00497497
- Acronym / sponsor ID
- APM4187g
- Conditions
- Colorectal Cancer
- Keywords
- CRC, Colon cancer, Avastin, APM4187g
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Jul 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 is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cetuximab, Drug: irinotecan, Drug: PRO95780 |
| 2 | Experimental | Drug: bevacizumab, Drug: FOLFIRI regimen, Drug: PRO95780 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Age ≥ 18 years
- Histologically confirmed CRC with evidence of metastases and measurable tumor lesions
- Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy
- Life expectancy > 3 months
Key exclusion criteria (18 listed)
- Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens
- Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
- Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field
- Recent chemotherapy, hormonal therapy, or immunotherapy
- Evidence of clinically detectable ascites
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 |
|---|---|---|
| bevacizumab(Only for patients not previously treated with bevacizumab) Intravenous repeating dose | Drug | 2 |
| cetuximabIntravenous repeating dose | Drug | 1 |
| FOLFIRI regimenIntravenous repeating dose | Drug | 2 |
| irinotecanIntravenous repeating dose | Drug | 1 |
| PRO95780Intravenous repeating dose | Drug | 1, 2 |
Primary outcome
Incidence and nature of dose-limiting toxicities
Time frame: Through study completion or early study discontinuation
3 secondary outcomes
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation
Change in vital signs
Time frame: Through study completion or early study discontinuation
Incidence and severity of infusion reactions
Time frame: Through study completion or early study discontinuation
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 19 May 2017.
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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.
Gordon Bray, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bevacizumab, cetuximab and FOLFIRI regimen in people with Colorectal Cancer, run by Genentech, Inc..
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 7 inclusion and 18 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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: Through study completion or early study discontinuation). 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 19 May 2017.