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TerminatedNCT02720796Updated Oct 6, 2017

Patient-Derived Xenograft (PDX) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma

An interventional study of PDX drug sensitivity testing in Sarcoma, sponsored by Champions Oncology. Terminated at 1 site in Canada. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2017-10-06.

Sponsored by Champions Oncology · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Recruitment barriers
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
15 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Sarcoma

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Keywords

  • PDX
  • TumorGraft
  • Patient derived xenograft
  • sarcoma
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In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 17 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

This is the only study on the registry with Champions Oncology as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • 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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Other
    PDX drug sensitivity testing

    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.

    Other: PDX drug sensitivity testing

Interventions

  • OtherPDX drug sensitivity testing

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

Secondary outcomes

  1. 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.

    Time frame: 3 years

  2. Factors that impact on engraftment success.

    % engraftment of tumor as a function of patient and tumor characteristics.

    Time frame: 2 years

  3. Factors that impact time to drug sensitivity testing.

    Time to PDX drug sensitivity testing as a function of patient and tumor characteristics.

    Time frame: 2 years

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Study locations

1 site
  • Mount Sinai Hospital
    Toronto, Ontario M5G 1X5, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02720796
Lead sponsor
Champions Oncology
Collaborators
Mount Sinai Hospital, Canada
Responsible party
Sponsor
First posted
Mar 28, 2016
Start date
Nov 2015
Primary completion
Nov 30, 2017 (estimated)
Completion
Nov 30, 2017 (estimated)
Last update
Oct 6, 2017

Study contacts

Albiruni Razak, MD
principal investigator · Mount Sinai Hospital, Toronto, Ontario, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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