CancerPhase 1NCT00492830
Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing TRC093 recombinant humanized IgG1k monoclonal antibody in people with Cancer and Neoplasm Metastasis, run by Tracon Pharmaceuticals Inc. at 3 sites in United States.
Trial summary
This study is being performed to evaluate the safety and tolerability of the TRC093 antibody. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Neoplasm Metastasis
- What is being tested?
- TRC093 recombinant humanized IgG1k monoclonal antibody
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2007to Nov 2009
- 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
- A patient will be eligible for study participation only if all of the following criteria apply:
- The patient has given informed consent.
- The patient is willing and able to abide by the protocol.
- The patient is at least 18 years old.
- The patient has advanced cancer and is not eligible for treatment or no effective treatment exists.
- Significant toxicities resulting from prior therapy must have recovered.
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- If the patient is a female of childbearing potential, she is using an acceptable/effective method of contraception.
- If the patient is a female, she has had a negative serum pregnancy test within the past 30 days.
- The patient has adequate ability to perform activities of daily living.
- The patient has adequate organ function as assessed by laboratory tests
Who cannot join
- A patient will not be eligible for study participation if any of the following criteria apply:
- The patient weighs more than 264 lbs.
- The patient has had a major surgical procedure, or significant injury within the past 28 days or there is an anticipation of the need for major surgery during the course of the study.
- The patient has received treatment for their cancer, including radiation (minimal amount of localized radiation may be allowed), within the past 28 days.
- The patient has known brain tumors.
- The patient experienced blood clots within six months prior to study start.
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- The patient has a non-healing wound, ulcer or bone fracture.
- The patient received recent thrombolytic or anticoagulant therapy.
- The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
- The patient enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
- The patient is receiving, or plans to receive, an anti-cancer therapy during the study with the exception of patients receiving chronic luteinizing hormone-releasing hormone (LHRH) agonists.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Birmingham, Alabama
Study site
Phoenix, Arizona
Study site
Santa Monica, California
About this study
Official title: A Phase 1, Open-label, Dose Escalation Study of the Humanized Monoclonal Antibody, TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors
This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.
Read the detailed description
In addition to safety, this study will also evaluate pharmacokinetics, tumor response, and anti-TRC093 antibody formation.
- Conditions
- Cancer, Neoplasm Metastasis
- Being tested
- TRC093 recombinant humanized IgG1k monoclonal antibody
- Keywords
- Phase 1, TRC093, denatured collagen, solid tumor, antibody, TRACON, Locally advanced solid tumors, Metastatic solid tumors
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRC093 recombinant humanized IgG1k monoclonal antibodyDrug
TRC093 is a humanized monoclonal antibody to cleaved collagen administered i.v. on days 1 and 15 of each 28 day cycle until pregression or unacceptable toxicity develops.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be evaluated
Measured: Through last patient last visit
Dose Limiting Toxicities
Measured: 28 day evaluation period
Secondary outcomes (2)
Pharmacokinetics of TRC093 monoclonal antibody
Measured: Through last patient last visit
Number of responses by tumor type
Measured: Through last patient last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tracon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492830
- Sponsor's protocol ID
- 093ST101
- Status last verified
- Feb 2010
- First submitted
- 25 Jun 2007
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose Escalation Study of the Humanized Monoclonal Antibody, TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00492830
- Acronym / sponsor ID
- 093ST101
- Conditions
- Cancer, Neoplasm Metastasis
- Keywords
- Phase 1, TRC093, denatured collagen, solid tumor, antibody, TRACON, Locally advanced solid tumors, Metastatic solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Tracon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Jun 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 study is being performed to evaluate the safety and tolerability of the TRC093 antibody.
Detailed description
In addition to safety, this study will also evaluate pharmacokinetics, tumor response, and anti-TRC093 antibody formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A patient will be eligible for study participation only if all of the following criteria apply:
- The patient has given informed consent.
- The patient is willing and able to abide by the protocol.
- The patient is at least 18 years old.
- The patient has advanced cancer and is not eligible for treatment or no effective treatment exists.
Key exclusion criteria (11 listed)
- A patient will not be eligible for study participation if any of the following criteria apply:
- The patient weighs more than 264 lbs.
- The patient has had a major surgical procedure, or significant injury within the past 28 days or there is an anticipation of the need for major surgery during the course of the study.
- The patient has received treatment for their cancer, including radiation (minimal amount of localized radiation may be allowed), within the past 28 days.
- The patient has known brain tumors.
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 |
|---|---|---|
| TRC093 recombinant humanized IgG1k monoclonal antibodyTRC093 is a humanized monoclonal antibody to cleaved collagen administered i.v. on days 1 and 15 of each 28 day cycle until pregression or unacceptable toxicity develops. | Drug | – |
Primary outcome
Safety and tolerability will be evaluated
Time frame: Through last patient last visit
Dose Limiting Toxicities
Time frame: 28 day evaluation period
2 secondary outcomes
Pharmacokinetics of TRC093 monoclonal antibody
Time frame: Through last patient last visit
Number of responses by tumor type
Time frame: Through last patient last visit
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 5 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 TRC093 recombinant humanized IgG1k monoclonal antibody in people with Cancer and Neoplasm Metastasis, run by Tracon Pharmaceuticals Inc. 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 10 inclusion and 11 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 5 Feb 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?
Safety and tolerability will be evaluated (time frame: Through last patient last visit). 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 5 Feb 2010.