Advanced Solid TumorsPhase 1NCT00879684
Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
A Phase 1 study testing CVX-060 in people with Advanced Solid Tumors and Neoplasms, run by Pfizer at 4 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Neoplasms, Carcinoma
- What is being tested?
- CVX-060
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2008to Apr 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
- Adequate coagulation, liver, and renal function.
- Candidate for DCE-MRI evaluations.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Who cannot join
- Evidence of significant bleeding problems.
- History of certain gastrointestinal problems including fistula and abscess.
- Chronic, uncontrolled hypertension.
- Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Premiere Oncology, A Medical Corporation
Santa Monica, California, 90404
Scottsdale Medical Imaging, Ltd.
Scottsdale, Arizona, 85255
Premiere Oncology of Arizona
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, Malignancy
- Being tested
- CVX-060
- Keywords
- Phase 1, Tumors, CVX-060
- Medical subject headings
- Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVX-060Biological
Weekly, intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: CVX-060 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: Baseline (Day 0) up to 30 days after last dose of study medication
Secondary outcomes (10)
Maximum Observed Serum Concentration (Cmax)
Measured: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Serum Decay Half-Life (t1/2)
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Measured: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]
AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).
Measured: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Apparent Volume of Distribution (Vss)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.
Measured: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Apparent Clearance (CL)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
Measured: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Time to Reach Maximum Observed Serum Concentration (Tmax)
Measured: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Recommended Phase 2 Dose (RP2D): Stage 1
RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.
Measured: Baseline (Day 0) up to 42 days after the last dose of study medication
Number of Participants With Anti-CVX-060 Antibodies
Measured: Baseline (Day 0) up to 42 days after last dose
Number of Samples From Participants With Anti-CVX-060 Antibodies
Measured: Baseline (Day 0) up to 42 days after last dose
Number of Participants With Best Overall Response (BOR)
BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported.
Measured: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879684
- Sponsor's protocol ID
- B1131002
- Other IDs
- CVX-060-101
- Status last verified
- Jan 2015
- First submitted
- 9 Apr 2009
- Last updated
- 26 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00879684
- Acronym / sponsor ID
- B1131002
- Conditions
- Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, Malignancy
- Keywords
- Phase 1, Tumors, CVX-060
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Posted 26 Jan 2015
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 study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CVX-060 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
- Adequate coagulation, liver, and renal function.
- Candidate for DCE-MRI evaluations.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Key exclusion criteria (4 listed)
- Evidence of significant bleeding problems.
- History of certain gastrointestinal problems including fistula and abscess.
- Chronic, uncontrolled hypertension.
- Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
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 |
|---|---|---|
| CVX-060Weekly, intravenous dose | Biological | 1 |
Primary outcome
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline (Day 0) up to 30 days after last dose of study medication
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
10 secondary outcomes
Maximum Observed Serum Concentration (Cmax)
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Serum Decay Half-Life (t1/2)
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Apparent Volume of Distribution (Vss)
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Apparent Clearance (CL)
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Recommended Phase 2 Dose (RP2D): Stage 1
Time frame: Baseline (Day 0) up to 42 days after the last dose of study medication
Number of Participants With Anti-CVX-060 Antibodies
Time frame: Baseline (Day 0) up to 42 days after last dose
Number of Samples From Participants With Anti-CVX-060 Antibodies
Time frame: Baseline (Day 0) up to 42 days after last dose
Number of Participants With Best Overall Response (BOR)
Time frame: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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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.
Pfizer CT.gov Call Center study director
Pfizer
4 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 CVX-060 in people with Advanced Solid Tumors and Neoplasms, run by Pfizer at 4 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 4 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) (time frame: Baseline (Day 0) up to 30 days after last dose of study medication). 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 26 Jan 2015.