Metastatic Colorectal CancerPhase 2VengeanceNCT01249521
Dual Targeting of Vascular Endothelial Growth Factor-A Together With Angiopoietins in Chemotherapy-naïve Metastatic Colorectal Cancer
A Phase 2 study testing AMG386 and bevacizumab in people with Metastatic Colorectal Cancer, run by Austin Health at 1 site in Australia.
Trial summary
This is a clinical trial investigating the effectiveness and safety of the combination of the study drugs bevacizumab and AMG386 in patients with advanced (metastatic) chemotherapy-naive bowel (colorectal) cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- AMG386 and bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2010to Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histological diagnosis of colorectal cancer ii) Metastatic disease that is not resectable iii) Age > 18 years iv) Any patient in whom the investigator considers immediate cytotoxic chemotherapy is not required.
- Measurable and/or non-measurable disease as assessed by CT scan vi) ECOG performance status 0, 1 or 2. vii) No prior chemotherapy except for adjuvant chemotherapy. viii) Adequate bone marrow function with platelets > 100 X 109/l; neutrophils > 1.5 X 109/l ix) Adequate renal function, with calculated creatinine clearance >40 ml/min (Cockcroft and Gault).
- Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range xi) Life expectancy of at least 12 weeks xii) No other concurrent uncontrolled medical conditions xiii) No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse xiv) Women and partners of women of childbearing potential must agree to use adequate contraception xv) Written informed consent including consent for biomarker studies
Who cannot join
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol ii) Uncontrolled hypertension iii) Prior treatment with VEGF inhibitors or angiopoietin inhibitors iv) Active bleeding disorders within the last 6 months v) Participation in any investigational drug study within the previous 4 weeks vi) Patients with uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris vii) Patients with a history of arterial or venous thrombosis within the last 12 months viii) Concurrent or prior (within 1 week before enrollment) anticoagulation therapy. The concurrent use of low molecular weight heparin or low dose warfarin (ie, 1 mg daily) for prophylaxis against thrombosis is acceptable while on study ix) Regular use of aspirin (>325mg/day) or NSAIDs (low dose aspirin (<325 mg/d), or occasional use of NSAIDs is acceptable) x) Treatment with immune modulators such as cyclosporine or tacrolimus within the previous 4 weeks xi) CNS metastases xii) Major surgical procedure within the last 28 days xiii) Minor surgical procedure, placement of access device, or fine needle aspiration within the last 7 days xiv) Serious non-healing wound, ulcer or bone fracture xv) 24 hour urinary protein > 1g/ 24 hours ( performed if urine dipstick > 1+ ) xvi) Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Austin Health
Melbourne, Victoria, 3084
Effie Skrinos, +61394963576, effie.skrinos@austin.org.au
Niall Tebbutt
About this study
Official title: Open Label Phase II Study Evaluating the Combination of Bevacizumab and AMG386 Without Chemotherapy as First Line Treatment of Advanced Colorectal Cancer
This is a clinical trial investigating the effectiveness and safety of the combination of the study drugs bevacizumab and AMG386 in patients with advanced (metastatic) chemotherapy-naive bowel (colorectal) cancer. Chemotherapy has a significant impact in metastatic bowel cancer in terms of maintenance of quality of life and extension of survival. However, ultimately tumours will develop resistance to these agents and further treatment options are urgently required.
Angiogenesis is a process that results in the formation of new blood vessels. Similar to normal tissues, solid tumours require new blood vessels for growth and survival. Hence, drugs targeting angiogenesis may be useful treatment options for patients with bowel cancer.
Read more
AMG386 and bevacizumab act on 2 different pathways relevant to angiogenesis. There is evidence from laboratory and animal studies to suggest that such a combination could be useful as a cancer treatment. Previous studies in humans have shown that AMG386 and bevacizumab can be combined safely.. This study aims to evaluate the effectiveness and safety of the combination of AMG386 and bevacizumab in patients with advanced bowel cancer.
40 patients from approximately four hospitals in Australia will participate in this trial, with approximately 20 patients being enrolled at Austin Health. All participants will receive the same treatment.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- AMG386 and bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG386 and bevacizumabDrug
AMG386 10mg/kg qw iv Bevacizumab 7.5mg/kg q3w iv
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control (ie non progression) at 6 months
Measured: 6 months
Secondary outcomes (3)
Toxicity
Measured: weekly
Overall survival
Measured: 3 monthly
Response rate
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2011 (estimated)
- Study completionNov 2012 (estimated)
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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Investigators
- Niall Tebbutt, Study chair, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249521
- Sponsor's protocol ID
- 03501
- Acronym
- Vengeance
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase II Study Evaluating the Combination of Bevacizumab and AMG386 Without Chemotherapy as First Line Treatment of Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01249521
- Acronym / sponsor ID
- Vengeance / 03501
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Austin HealthOther government
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 30 Nov 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.
This is a clinical trial investigating the effectiveness and safety of the combination of the study drugs bevacizumab and AMG386 in patients with advanced (metastatic) chemotherapy-naive bowel (colorectal) cancer. Chemotherapy has a significant impact in metastatic bowel cancer in terms of maintenance of quality of life and extension of survival. However, ultimately tumours will develop resistance to these agents and further treatment options are urgently required.
Angiogenesis is a process that results in the formation of new blood vessels. Similar to normal tissues, solid tumours require new blood vessels for growth and survival. Hence, drugs targeting angiogenesis may be useful treatment options for patients with bowel cancer.
AMG386 and bevacizumab act on 2 different pathways relevant to angiogenesis. There is evidence from laboratory and animal studies to suggest that such a combination could be useful as a cancer treatment. Previous studies in humans have shown that AMG386 and bevacizumab can be combined safely.. This study aims to evaluate the effectiveness and safety of the combination of AMG386 and bevacizumab in patients with advanced bowel cancer.
40 patients from approximately four hospitals in Australia will participate in this trial, with approximately 20 patients being enrolled at Austin Health. All participants will receive the same treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Histological diagnosis of colorectal cancer ii) Metastatic disease that is not resectable iii) Age > 18 years iv) Any patient in whom the investigator considers immediate cytotoxic chemotherapy is not required.
- Measurable and/or non-measurable disease as assessed by CT scan vi) ECOG performance status 0, 1 or 2. vii) No prior chemotherapy except for adjuvant chemotherapy. viii) Adequate bone marrow function with platelets > 100 X 109/l; neutrophils > 1.5 X 109/l ix) Adequate renal function, with calculated creatinine clearance >40 ml/min (Cockcroft and Gault).
- Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range xi) Life expectancy of at least 12 weeks xii) No other concurrent uncontrolled medical conditions xiii) No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse xiv) Women and partners of women of childbearing potential must agree to use adequate contraception xv) Written informed consent including consent for biomarker studies
Key exclusion criteria (1 listed)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol ii) Uncontrolled hypertension iii) Prior treatment with VEGF inhibitors or angiopoietin inhibitors iv) Active bleeding disorders within the last 6 months v) Participation in any investigational drug study within the previous 4 weeks vi) Patients with uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris vii) Patients with a history of arterial or venous thrombosis within the last 12 months viii) Concurrent or prior (within 1 week before enrollment) anticoagulation therapy. The concurrent use of low molecular weight heparin or low dose warfarin (ie, 1 mg daily) for prophylaxis against thrombosis is acceptable while on study ix) Regular use of aspirin (>325mg/day) or NSAIDs (low dose aspirin (<325 mg/d), or occasional use of NSAIDs is acceptable) x) Treatment with immune modulators such as cyclosporine or tacrolimus within the previous 4 weeks xi) CNS metastases xii) Major surgical procedure within the last 28 days xiii) Minor surgical procedure, placement of access device, or fine needle aspiration within the last 7 days xiv) Serious non-healing wound, ulcer or bone fracture xv) 24 hour urinary protein > 1g/ 24 hours ( performed if urine dipstick > 1+ ) xvi) Pregnancy or lactation
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 |
|---|---|---|
| AMG386 and bevacizumabAMG386 10mg/kg qw iv Bevacizumab 7.5mg/kg q3w iv | Drug | – |
Primary outcome
Disease control (ie non progression) at 6 months
Time frame: 6 months
3 secondary outcomes
Toxicity
Time frame: weekly
Overall survival
Time frame: 3 monthly
Response rate
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
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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.
Niall Tebbutt study chair
Austin Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG386 and bevacizumab in people with Metastatic Colorectal Cancer, run by Austin Health at 1 site in Australia.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Effie Skrinos (+61394963576, effie.skrinos@austin.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control (ie non progression) at 6 months (time frame: 6 months). 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 30 Nov 2010.