Advanced Solid TumorsPhase 1NCT00688415
Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer
A Phase 1 study testing VTX-2337 in people with Advanced Solid Tumors and Lymphoma, run by Celgene at 2 sites in United States.
Trial summary
This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Lymphoma
- What is being tested?
- VTX-2337
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2008to 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
- Ability and willingness to provide written informed consent
- Histologically or cytologically confirmed solid tumors or lymphoma
- Locally advanced or metastatic disease
- Life expectancy of at least 16 weeks
- ECOG performance status of 0 or 1
- Acceptable physical exam and laboratory tests at study entry
- Willingness to use medically acceptable contraception
- A negative serum pregnancy test for women with reproductive potential
Who cannot join
- Anticancer therapy within 2 weeks
- Treatment with an investigational agent within 4 weeks
- Systemic corticosteroids within 2 weeks or a requirement for systemic immunosuppressive therapy
- Known brain metastases unless stable for at least 28 days
- Active autoimmune disease
- Insulin-dependent diabetes mellitus
Show all 10Show fewer
- Clinically significant cardiac disease within 6 months
- Significant infection or fever within 1 week
- Pregnant or breast-feeding females
- Other conditions or circumstances that could interfere with the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Scottsdale, Arizona
Scottsdale Healthcare
Scottsdale, Arizona
About this study
Official title: A Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacology of VTX-2337 When Administered to Adult Subjects With Advanced Solid Tumors or Lymphoma
This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.
- Conditions
- Advanced Solid Tumors, Lymphoma
- Being tested
- VTX-2337
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTX-2337Drug
Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and identification of dose-limiting toxicities
Measured: Study duration
Pharmacokinetics
Measured: First dose of investigational drug
Secondary outcomes (2)
Pharmacodynamics
Measured: Study duration
Identification of the MTD
Measured: First cycle of investigational drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study start7 Nov 2008
- Primary completionAug 2010
- 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 CelgeneThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amar Patel, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688415
- Sponsor's protocol ID
- VRXP-A101
- Status last verified
- Sep 2019
- First submitted
- 29 May 2008
- Last updated
- 25 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacology of VTX-2337 When Administered to Adult Subjects With Advanced Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT00688415
- Acronym / sponsor ID
- VRXP-A101
- Conditions
- Advanced Solid Tumors, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2008 (actual)
- Primary completion
- Aug 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 3 Jun 2008 (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 multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.
Study design
- Primary purpose
- Other
- 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 (8 listed)
- Ability and willingness to provide written informed consent
- Histologically or cytologically confirmed solid tumors or lymphoma
- Locally advanced or metastatic disease
- Life expectancy of at least 16 weeks
- ECOG performance status of 0 or 1
Key exclusion criteria (10 listed)
- Anticancer therapy within 2 weeks
- Treatment with an investigational agent within 4 weeks
- Systemic corticosteroids within 2 weeks or a requirement for systemic immunosuppressive therapy
- Known brain metastases unless stable for at least 28 days
- Active autoimmune disease
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 |
|---|---|---|
| VTX-2337Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified. | Drug | – |
Primary outcome
Safety and identification of dose-limiting toxicities
Time frame: Study duration
Pharmacokinetics
Time frame: First dose of investigational drug
2 secondary outcomes
Pharmacodynamics
Time frame: Study duration
Identification of the MTD
Time frame: First cycle of investigational drug
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 25 Sep 2019.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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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)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Amar Patel, MD study director
Celgene
2 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 VTX-2337 in people with Advanced Solid Tumors and Lymphoma, run by Celgene at 2 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 8 inclusion and 10 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 identification of dose-limiting toxicities (time frame: Study duration). 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 25 Sep 2019.