SarcomaNCT02720796
Patient-Derived Xenograft (PDX) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
A study testing PDX drug sensitivity testing in people with Sarcoma, run by Champions Oncology at 1 site in Canada.
Trial summary
Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- PDX drug sensitivity testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to 30 Nov 2017
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- 15 years of age or older
- Patients with metastatic sarcoma who have had no more than one prior systemic treatment for metastatic disease
- Patients with recurrent sarcoma at relapse
- Patients with confirmed histological diagnosis of sarcoma or suspected diagnosis of sarcoma. Some specific subtypes of sarcoma are NOT eligible (Gastrointestinal Stromal Tumor (GIST), carcinosarcoma, sarcomatoid mesothelioma, and metastatic phyllodes tumor)
- If initial suspected diagnosis of sarcoma, must have sarcoma diagnosis confirmed prior to proceeding with PDX drug sensitivity testing
- Must have measureable disease for computed tomography (CT) scan or magnetic resonance imaging (MRI) evaluation following biopsy or surgery to obtain tissue for PDX development.
- No plan for concurrent chemoradiation, for target lesions that will be used for drug treatment correlation with PDX
- Fresh tumor tissue available for PDX development
- Eastern Cooperative Oncology Group performance status of 0-1
- Life expectancy exceeds 6 months
- Plan to receive systemic therapy
- Informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Correlative Trial of Personalized Patient-Derived Xenograft (PDX or TumorGraft) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX) model in predicting patient clinical response to the same drug treatment.
- Conditions
- Sarcoma
- Being tested
- PDX drug sensitivity testing
- Keywords
- PDX, TumorGraft, Patient derived xenograft, sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDX drug sensitivity testingOther
Patient derived xenograft (PDX) models will be developed for each patient and drug activity assessed in their personalized PDX model. PDX drug sensitivity information will be provided to the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| PDX drug sensitivity testing | Other | Patient derived xenograft (PDX) models will be developed for each patient and drug activity assessed in their personalized PDX model. PDX drug sensitivity information will be provided to the treating physician. Receives: Other: PDX drug sensitivity testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment.
Overall accuracy as assessed by evaluating Response Evaluation Criteria In Solid Tumors (RECIST) criteria in patient tumor and correlating to tumor regression in PDX model for same drug treatment.
Measured: 3 years
Secondary outcomes (3)
Number of patients' whose personalized PDX model accurately predicts clinical response to therapy over subsequent lines of therapy.
Overall accuracy as assessed by evaluating RECIST criteria in patient and correlating to tumor regression in PDX model for same drug treatment, over subsequent lines of therapy.
Measured: 3 years
Factors that impact on engraftment success.
% engraftment of tumor as a function of patient and tumor characteristics.
Measured: 2 years
Factors that impact time to drug sensitivity testing.
Time to PDX drug sensitivity testing as a function of patient and tumor characteristics.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startNov 2015
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Why it stopped: Recruitment barriers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Champions Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Albiruni Razak, MD, Principal investigator, Mount Sinai Hospital, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720796
- Sponsor's protocol ID
- CO-001
- Status last verified
- Oct 2017
- First submitted
- 5 Nov 2015
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Correlative Trial of Personalized Patient-Derived Xenograft (PDX or TumorGraft) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
- ClinicalTrials.gov ID
- NCT02720796
- Acronym / sponsor ID
- CO-001
- Conditions
- Sarcoma
- Keywords
- PDX, TumorGraft, Patient derived xenograft, sarcoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment barriers
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Champions OncologyIndustry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, Canada
- Study start
- Nov 2015
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 28 Mar 2016 (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.
Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX) model in predicting patient clinical response to the same drug treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDX drug sensitivity testing | Other | Other: PDX drug sensitivity testingPatient derived xenograft (PDX) models will be developed for each patient and drug activity assessed in their personalized PDX model. PDX drug sensitivity information will be provided to the treating physician. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| PDX drug sensitivity testingPatient derived xenograft (PDX) models will be developed for each patient and drug activity assessed in their personalized PDX model. PDX drug sensitivity information will be provided to the treating physician. | Other | PDX drug sensitivity testing |
Primary outcome
Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment.
Time frame: 3 years
Overall accuracy as assessed by evaluating Response Evaluation Criteria In Solid Tumors (RECIST) criteria in patient tumor and correlating to tumor regression in PDX model for same drug treatment.
3 secondary outcomes
Number of patients' whose personalized PDX model accurately predicts clinical response to therapy over subsequent lines of therapy.
Time frame: 3 years
Factors that impact on engraftment success.
Time frame: 2 years
Factors that impact time to drug sensitivity testing.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Recruitment barriers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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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.
Albiruni Razak, MD principal investigator
Mount Sinai Hospital, Toronto, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDX drug sensitivity testing in people with Sarcoma, run by Champions Oncology at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 6 Oct 2017. 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 Canada. 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.
Are results available for this study?
The study was stopped early (reason given: Recruitment barriers). Results are not available in the source record.
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 patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment. (time frame: 3 years). 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 6 Oct 2017.