Advanced Solid TumorsPhase 1CVX-045-101NCT00879554
A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors
A Phase 1 study testing CVX-045 in people with Advanced Solid Tumors and Neoplasms, run by Pfizer at 3 sites in United States.
Trial summary
The purpose of the study is to determine safety and tolerability of CVX-045 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-045
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Nov 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
- 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 evaluation.
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
Who cannot join
- Evidence of bleeding problems.
- Uncontrolled hypertension.
- Certain gastrointestinal problems including fistula and abscess.
- Patients with primary brain cancer.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Scottsdale, Arizona, 85258
About this study
Official title: A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, In Patients With Advanced Solid Tumors
The purpose of the study is to determine safety and tolerability of CVX-045 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, Malignancy
- Being tested
- CVX-045
- Keywords
- Phase 1, Solid Tumors, CVX-045
- 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-045Biological
Weekly, intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: CVX-045 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors
Measured: Throughout duration of study
To identify and characterize CVX-045-related adverse events (AEs)
Measured: Throughout duration of study
Secondary outcomes (4)
To evaluate the plasma pharmacokinetics (PK) of CVX-045
Measured: Days 1, 4, 8, 15, 29
To determine a recommended Phase 2 dose of CVX-045
Measured: End of study
To evaluate the potential for immunogenicity of CVX-045
Measured: Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU
To document any preliminary evidence of antitumor activity
Measured: Every 8 weeks
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 startFeb 2007
- Primary completionMar 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879554
- Sponsor's protocol ID
- B1121003
- Acronym
- CVX-045-101
- Status last verified
- Dec 2010
- First submitted
- 9 Apr 2009
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, In Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00879554
- Acronym / sponsor ID
- CVX-045-101 / B1121003
- Conditions
- Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, Malignancy
- Keywords
- Phase 1, Solid Tumors, CVX-045
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 10 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 the study is to determine safety and tolerability of CVX-045 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-045 |
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 evaluation.
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
Key exclusion criteria (4 listed)
- Evidence of bleeding problems.
- Uncontrolled hypertension.
- Certain gastrointestinal problems including fistula and abscess.
- Patients with primary brain cancer.
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-045Weekly, intravenous dose | Biological | 1 |
Primary outcome
To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors
Time frame: Throughout duration of study
To identify and characterize CVX-045-related adverse events (AEs)
Time frame: Throughout duration of study
4 secondary outcomes
To evaluate the plasma pharmacokinetics (PK) of CVX-045
Time frame: Days 1, 4, 8, 15, 29
To determine a recommended Phase 2 dose of CVX-045
Time frame: End of study
To evaluate the potential for immunogenicity of CVX-045
Time frame: Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU
To document any preliminary evidence of antitumor activity
Time frame: Every 8 weeks
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 13 Dec 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Advanced Solid Tumors
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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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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
3 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-045 in people with Advanced Solid Tumors and Neoplasms, run by Pfizer at 3 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 13 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors (time frame: Throughout duration of study). 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 13 Dec 2010.