Solid TumorsPhase 1CNTO95/AvastinNCT00888043
Safety/Biomarker Study of CNTO 95 and Avastin in Solid Tumors
A Phase 1 study testing CNTO 95 and avastin in people with Solid Tumors, run by Herbert Hurwitz, MD at 1 site in United States.
Trial summary
The purpose of this research study is to find out what side effects the combination of the two study drugs, bevacizumab (Avastin) and CNTO 95 have on the body and to determine the highest dose of CNTO 95 that can be given with bevacizumab that is safe and well tolerated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- CNTO 95 and avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jan 2015
- 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 or cytologically confirmed diagnosis of advanced solid tumor refractory to standard therapy or for whom there is no standard therapy. Disease must be measurable by RECIST criteria.
- Age ≥ 18 years.
- Karnofsky performance status ≥ 70%.
- Life expectancy of at least 3 months.
- Patients must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/μl Platelets ≥ 100,000/μl Total bilirubin ≤ 1.5 X upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 2.5 X ULN, ≤ 5 X ULN if known hepatic metastases Creatinine clearance ≥ 50 mL/min/m2 for patients with creatinine levels (by Cockroft-Gault equation or 24 hour urine) Hemoglobin > 9 g/dL Continuation of erythropoietin products is permitted. Hemoglobin must be stable above 9 g/dL for at least 2 weeks without blood transfusion to maintain hemoglobin level.
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- Calcium (corrected for albumin) > 8.7 mg/dL
- The effect of the investigational drugs on the developing human fetus is not known, but these drugs are likely to be embryo- and feto- toxic. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician and study PI immediately. Subjects who are pregnant and/or lactating are excluded from this study.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects who have had radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for cancer within the 28 days prior to day 1 of study treatment. Subjects must not have had major surgery within the 28 days prior to study treatment day 1 or minor surgical procedures within the 7 days prior to study treatment day 1.
- Subjects who have received any other investigational agents within the 28 days prior to day 1 of the study.
- Subjects with known CNS metastases, centrally located non-small cell lung cancer (regardless of histologic sub-type), non-small cell lung cancer of squamous histology, and/or history of hemoptysis (> ½ tsp BRB).
- Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg). Initiation of antihypertensive is permitted provided adequate control is documented 3 times over at least 1 week before starting treatment.
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Evidence of bleeding diathesis or coagulopathy. Subjects on therapeutic anticoagulation may be enrolled provided that they have been clinically stable on anti-coagulation for at least 2 weeks.
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- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study treatment (56 days for hepatectomy, open thoracotomy, major neurosurgery) or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure excluding study-related procedures or placement of a vascular access device, within 7 days prior to expected start of treatment.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening as demonstrated by either urine protein:creatinine (UPC) ratio ≥ 1.0 or 24hr collection >1g/24hr at screening
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to day 1 of study treatment
- History of stroke or transient ischemic attack within 6 months prior to day 1 of study treatment
- History of intolerance or hypersensitivity to prior treatment with bevacizumab or CNTO 95. Prior treatment with these agents is permitted, as long as prior treatment was with only one agent at a time (ie - subjects may not have previously received bevacizumab and CNTO 95 together).
- Chronic treatment with systemic steroids or another immunosuppressive agent, though steroids may be used on an as-needed basis - ie - for treatment of nausea. Treatment with megace or low dose glucocorticoids is permitted for treatment of anorexia.
- Other known concurrent severe and/or uncontrolled medical disease which could compromise safety of treatment as so judged by treating physician (i.e., severely impaired lung function, uncontrolled diabetes (history of consistent blood glucose readings above 300 mg/dL or less than 50 mg/dL), uncontrolled hypertension (greater than 150/100), severe infection, severe malnutrition, ventricular arrhythmias active ischemic heart disease, known active vasculitis of any cause, tumor invasion of any major blood vessel, chronic liver or renal disease, active upper GI tract ulceration)
- A known history of HIV seropositivity,hepatitis C virus, acute or chronic active hepatitis B infection, or other serious chronic infection requiring ongoing treatment.
- Subjects with an active, bleeding diathesis or on oral anti-vitamin K medication (except coumadin). No history of active GI bleeding or other major bleeding within previous 6 months.
- Subjects unwilling to or unable to comply with the protocol
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety or compliance with study requirements or may interfere with the interpretation of the results.
- Known history of anaphylaxis allergic reactions to human Ig therapy or polysorbate 80 (components of CNTO 95).
- Known history of uveitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: A Phase I/Biomarker Study of Bevacizumab in Combination With CNTO 95 in Patients With Refractory Solid Tumors
The purpose of this research study is to find out what side effects the combination of the two study drugs, bevacizumab (Avastin) and CNTO 95 have on the body and to determine the highest dose of CNTO 95 that can be given with bevacizumab that is safe and well tolerated.
Read the detailed description
Targeting molecular pathways of tumor growth has recently become a major focus of anti-cancer treatments. The VEGF pathway has demonstrated significant mitogenic activity for arterial, venous, and lymphatic endothelial cells, induction of vascular permeability for extracellular remodeling, and activity as an endothelial cell growth factor. The proof of principle that targeting the VEGF pathway as an anti-cancer therapy was demonstrated by the phase III trial of the anti-VEGF monoclonal antibody bevacizumab versus placebo in combination with chemotherapy for metastatic colorectal cancer. In this trial the addition of bevacizumab to chemotherapy showed a statistically significant improvement in overall survival for these subjects (11). Since this trial, the addition of bevacizumab to chemotherapy has been shown to be beneficial in non-small cell lung cancer subjects and metastatic breast cancer subjects (9, 12).
Integrins have been shown to be essential components of angiogenesis. One of the best-characterized integrins in tumor-induced angiogenesis is αvβ3. Angiogenesis dramatically up-regulates integrin αvβ3 expression by endothelial cells (13). Integrin αvβ3 has been linked to cell migration and invasion (14), and cell survival (15). Inhibition of αvβ3 results in apoptosis of endothelial cells (16) and inhibition of microvascular network formation (17). The signaling pathways activated by αvβ3 and VEGF act synergistically in the formation of microvascular networks (17). Both αvβ3 and VEGF activate Src, Ras, PI3K, and Erk cascades (18). CNTO 95 is a fully humanized monoclonal antibody that blocks integrin αvβ3 with high affinity.
The combination of different targeted therapies has the potential of providing a more complete inhibition of angiogenesis. It is our hypothesis that the combination of CNTO 95 and bevacizumab will be a safe and potentially efficacious anti-angiogenesis strategy for the treatment of adult solid tumors. This combination may have utility directly or may prove useful when subsequently combined with other anti-angiogenic agents or standard chemotherapy regimens. We also hypothesize that our clinical dermal wound angiogenesis assay will help quantify and characterize the anti-angiogenic contribution of each agent in this combination.
Bevacizumab (Avastin) is a humanized monoclonal antibody to VEGF. VEGF is known to play a pivotal role in tumor angiogenesis and is a significant mitogenic stimulus for arterial, venous and lymphatic endothelial cells. The addition of bevacizumab to chemotherapy has been shown to increase overall response rate, duration of response and survival for patients with metastatic colon cancer (4) and is beneficial in first line non-small cell lung cancer and metastatic breast cancer [1, 2], and second line metastatic colorectal cancer (7). VEGF signals through phosphotidylinositol 3-kinase (PI3K) and Akt as well as through the extracellular regulated kinase (ERK 1/2), a mitogen activated protein kinase (MAPK). VEGF's multiple biologic actions may be mediated by different pathways. Erikkson demonstrated that VEGF induced hyperpermeability was highly dependent on activation of the AKT pathway, while the angiogenic effect was largely unaffected by blocking this pathway and likely depended on ERK activation [3].
CNTO 95 is a fully human mAb immunoglobulin G (IgG) of the gamma isotype and kappa light chain that has been shown to have antiangiogenic and antitumor properties. Results of in vitro studies demonstrate that CNTO 95 is an anti-αv integrin antibody that binds and blocks integrin ανβ3 with high affinity. CNTO 95 has also been shown to bind to integrins ανβ1, ανβ5, and ανβ6. No cross-reactivity of CNTO 95 to glycoprotein IIb/IIIa, ανβ1 or platelets has been observed. By binding and blocking the ανβ3 and ανβ5 integrins, CNTO 95 can inhibit cell adhesion, migration, proliferation, and invasion of both tumor and endothelial cells in vitro. It is known that CNTO 95 binds to other αν integrins. However, the clinical implications of binding to these integrins are unknown.
- Conditions
- Solid Tumors
- Being tested
- CNTO 95 and avastin
- Keywords
- solid tumors, avastin, Phase I, combination therapy, bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 95 and avastinDrug
Also called bevacizumab
STAGE 1 (Dose escalation) Cohort # subjects CNTO 95 Bevacizumab
- 2 3-6 2.5 mg/kg IV Q3 weeks 7.5 mg/kg IV Q3 weeks
- 1 3-6 2.5 mg/kg IV Q3 weeks 15 mg/kg IV Q3 weeks
- 3-6 5 mg/kg IV Q3weeks 15 mg/kg IV Q3 weeks
- 3-6 10 mg/kg IV Q3 weeks 15 mg/kg IV Q3 weeks STAGE 2 (Biomarker) Cohort # subjects CNTO 95 Bevacizumab
- 20 Recommended Phase II Dose Recommended Phase II Dose
| Study group | Role | What they receive |
|---|---|---|
| I | Other | CNTO 95 and avastin Receives: Drug: CNTO 95 and avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define a recommended phase II dose for the combination of CNTO 95 plus bevacizumab in subjects with advanced solid tumors.
Measured: Every cycle (21 days)
To evaluate dose limiting as well as non-dose limiting toxicities of this combination.
Measured: Every cycle (21 days)
Secondary outcomes (1)
To explore the effect of the combination versus each agent individually on dermal wound angiogenesis in a skin biopsy, the clinical activity of this combination, and the association between blood- and urine-based biomarkers and clinical outcome.
Measured: Every cycle (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbert Hurwitz, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc., Genentech, Inc.
- Responsible party
- Sponsor-investigator, Herbert Hurwitz, MD, Duke University
- Investigators
- Herbert I Hurwitz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888043
- Sponsor's protocol ID
- Pro00004929
- Acronym
- CNTO95/Avastin
- Status last verified
- Mar 2015
- First submitted
- 23 Apr 2009
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Biomarker Study of Bevacizumab in Combination With CNTO 95 in Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00888043
- Acronym / sponsor ID
- CNTO95/Avastin / Pro00004929
- Conditions
- Solid Tumors
- Keywords
- solid tumors, avastin, Phase I, combination therapy, bevacizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Herbert Hurwitz, MDUniversity, hospital or other
- Collaborators
- Centocor, Inc., Genentech, Inc.
- Study start
- Mar 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 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.
The purpose of this research study is to find out what side effects the combination of the two study drugs, bevacizumab (Avastin) and CNTO 95 have on the body and to determine the highest dose of CNTO 95 that can be given with bevacizumab that is safe and well tolerated.
Detailed description
Targeting molecular pathways of tumor growth has recently become a major focus of anti-cancer treatments. The VEGF pathway has demonstrated significant mitogenic activity for arterial, venous, and lymphatic endothelial cells, induction of vascular permeability for extracellular remodeling, and activity as an endothelial cell growth factor. The proof of principle that targeting the VEGF pathway as an anti-cancer therapy was demonstrated by the phase III trial of the anti-VEGF monoclonal antibody bevacizumab versus placebo in combination with chemotherapy for metastatic colorectal cancer. In this trial the addition of bevacizumab to chemotherapy showed a statistically significant improvement in overall survival for these subjects (11). Since this trial, the addition of bevacizumab to chemotherapy has been shown to be beneficial in non-small cell lung cancer subjects and metastatic breast cancer subjects (9, 12).
Integrins have been shown to be essential components of angiogenesis. One of the best-characterized integrins in tumor-induced angiogenesis is αvβ3. Angiogenesis dramatically up-regulates integrin αvβ3 expression by endothelial cells (13). Integrin αvβ3 has been linked to cell migration and invasion (14), and cell survival (15). Inhibition of αvβ3 results in apoptosis of endothelial cells (16) and inhibition of microvascular network formation (17). The signaling pathways activated by αvβ3 and VEGF act synergistically in the formation of microvascular networks (17). Both αvβ3 and VEGF activate Src, Ras, PI3K, and Erk cascades (18). CNTO 95 is a fully humanized monoclonal antibody that blocks integrin αvβ3 with high affinity.
The combination of different targeted therapies has the potential of providing a more complete inhibition of angiogenesis. It is our hypothesis that the combination of CNTO 95 and bevacizumab will be a safe and potentially efficacious anti-angiogenesis strategy for the treatment of adult solid tumors. This combination may have utility directly or may prove useful when subsequently combined with other anti-angiogenic agents or standard chemotherapy regimens. We also hypothesize that our clinical dermal wound angiogenesis assay will help quantify and characterize the anti-angiogenic contribution of each agent in this combination.
Bevacizumab (Avastin) is a humanized monoclonal antibody to VEGF. VEGF is known to play a pivotal role in tumor angiogenesis and is a significant mitogenic stimulus for arterial, venous and lymphatic endothelial cells. The addition of bevacizumab to chemotherapy has been shown to increase overall response rate, duration of response and survival for patients with metastatic colon cancer (4) and is beneficial in first line non-small cell lung cancer and metastatic breast cancer [1, 2], and second line metastatic colorectal cancer (7). VEGF signals through phosphotidylinositol 3-kinase (PI3K) and Akt as well as through the extracellular regulated kinase (ERK 1/2), a mitogen activated protein kinase (MAPK). VEGF's multiple biologic actions may be mediated by different pathways. Erikkson demonstrated that VEGF induced hyperpermeability was highly dependent on activation of the AKT pathway, while the angiogenic effect was largely unaffected by blocking this pathway and likely depended on ERK activation [3].
CNTO 95 is a fully human mAb immunoglobulin G (IgG) of the gamma isotype and kappa light chain that has been shown to have antiangiogenic and antitumor properties. Results of in vitro studies demonstrate that CNTO 95 is an anti-αv integrin antibody that binds and blocks integrin ανβ3 with high affinity. CNTO 95 has also been shown to bind to integrins ανβ1, ανβ5, and ανβ6. No cross-reactivity of CNTO 95 to glycoprotein IIb/IIIa, ανβ1 or platelets has been observed. By binding and blocking the ανβ3 and ανβ5 integrins, CNTO 95 can inhibit cell adhesion, migration, proliferation, and invasion of both tumor and endothelial cells in vitro. It is known that CNTO 95 binds to other αν integrins. However, the clinical implications of binding to these integrins are unknown.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Other | Drug: CNTO 95 and avastinCNTO 95 and avastin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed diagnosis of advanced solid tumor refractory to standard therapy or for whom there is no standard therapy. Disease must be measurable by RECIST criteria.
- Age ≥ 18 years.
- Karnofsky performance status ≥ 70%.
- Life expectancy of at least 3 months.
- Patients must have adequate organ and marrow function as defined below:
Key exclusion criteria (24 listed)
- Subjects who have had radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for cancer within the 28 days prior to day 1 of study treatment. Subjects must not have had major surgery within the 28 days prior to study treatment day 1 or minor surgical procedures within the 7 days prior to study treatment day 1.
- Subjects who have received any other investigational agents within the 28 days prior to day 1 of the study.
- Subjects with known CNS metastases, centrally located non-small cell lung cancer (regardless of histologic sub-type), non-small cell lung cancer of squamous histology, and/or history of hemoptysis (> ½ tsp BRB).
- Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg). Initiation of antihypertensive is permitted provided adequate control is documented 3 times over at least 1 week before starting treatment.
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
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 |
|---|---|---|
| CNTO 95 and avastinAlso: bevacizumabSTAGE 1 (Dose escalation) Cohort # subjects CNTO 95 Bevacizumab * 2 3-6 2.5 mg/kg IV Q3 weeks 7.5 mg/kg IV Q3 weeks * 1 3-6 2.5 mg/kg IV Q3 weeks 15 mg/kg IV Q3 weeks 1. 3-6 5 mg/kg IV Q3weeks 15 mg/kg IV Q3 weeks 2. 3-6 10 mg/kg IV Q3 weeks 15 mg/kg IV Q3 weeks STAGE 2 (Biomarker) Cohort # subjects CNTO 95 Bevacizumab 3. 20 Recommended Phase II Dose Recommended Phase II Dose | Drug | I |
Primary outcome
To define a recommended phase II dose for the combination of CNTO 95 plus bevacizumab in subjects with advanced solid tumors.
Time frame: Every cycle (21 days)
To evaluate dose limiting as well as non-dose limiting toxicities of this combination.
Time frame: Every cycle (21 days)
1 secondary outcome
To explore the effect of the combination versus each agent individually on dermal wound angiogenesis in a skin biopsy, the clinical activity of this combination, and the association between blood- and urine-based biomarkers and clinical outcome.
Time frame: Every cycle (21 days)
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 11 Mar 2015.
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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.
Herbert I Hurwitz, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNTO 95 and avastin in people with Solid Tumors, run by Herbert Hurwitz, MD at 1 site 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 9 inclusion and 24 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 11 Mar 2015. 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 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?
To define a recommended phase II dose for the combination of CNTO 95 plus bevacizumab in subjects with advanced solid tumors. (time frame: Every cycle (21 days)). 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 11 Mar 2015.