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Study of Molecular Profile-Related Evidence to Determine Individualized Therapy for Advanced or Poor Prognosis Cancers (I-PREDICT)

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ClinicalTrials.gov Identifier: NCT02534675
Recruitment Status : Recruiting
First Posted : August 28, 2015
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Jason K. Sicklick, M.D., University of California, San Diego

Study Description
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Brief Summary:
The purpose of this study is to learn more about personalized cancer therapy including response to treatment and side effects. Information from the patient's medical record regarding the tests and treatments they have received, or will receive, for their cancer will be collected. Genomic testing on tissue from the primary tumor or metastases will be used to match therapy recommendations. Patients in which there is no appropriate matched therapy will receive systemic chemotherapy according to their treating physician's discretion. This information will be used to describe whether or not patients respond better when their physicians choose to treat them according to the genetic makeup of their tumor.

Condition or disease
Cancer

Detailed Description:
This is a prospective, open label navigational investigation to evaluate the feasibility of using molecular profile-based evidence to determine individualized cancer therapy for patients with incurable malignancies. This is a non-randomized, histology-agnostic trial. While it is known that individual histologies are composed of a heterogeneous mix of genomic alterations, it is not clear that one case mix is better or worse than another. Thus, a strategy of molecular matching that may apply across cancers is being tested. All eligible and consented patients will have their tumor tissues genomic profiled by Foundation Medicine's FoundationOne genomic analysis. Patients will be stratified into Group 1 (treatment naïve, unresectable/medically unfit for surgery), Group 2 (treatment naïve, metastatic), and Group 3 (prior treated), respectively. Following analysis for genomic alterations, matched therapy, if available, will be recommended by the Study Committee or Molecular Tumor Board. If the patients received the matched therapy, they are designated as in Arm A. Otherwise, if the patients received the unmatched therapy (i.e., treating physician's choice of traditional systemic chemotherapy), they are designated as in Arm B. The study feasibility will be measured by the ability to enroll patients, the acceptable turnaround time and the actionable information obtained from the genomic profiling, and the viability of identifying and delivering the matched therapy. The treatment efficacy will be determined among the patients groups and treatment arms. The safety profile of the treatment will also be assessed.

Study Design
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Study Type : Observational
Estimated Enrollment : 225 participants
Time Perspective: Prospective
Official Title: An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Malignancies and Poor Prognosis
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients who receive the molecularly targeted matched treatment after recommendations based on genomic analysis [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Proportion of patients who consent to enroll into the study [ Time Frame: 3 years ]
  2. Time from informed consent to receipt of genomic analysis [ Time Frame: 3 years ]
  3. Proportion of patients with actionable genomic alteration [ Time Frame: 3 years ]
  4. Proportion of patients with insurance coverage for receiving molecularly targeted matched treatment based on genomic analysis [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Primary tumor tissue or metastases

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with incurable malignancies with aggressive biology
Criteria

INCLUSION CRITERIA:

  • Patients with incurable malignancies with ≥50% 2-year cancer-associated mortality (as estimated by 2 physicians and where appropriate according to 2014 National Cancer Database).

  • Patients must have at least one of the following for diagnosis/disease status:

    • Unresectable disease
    • Metastatic disease
    • Medically unfit for surgical resection but with an expected survival of >3 months
    • Disease where no conventional therapy leads to a survival benefit >6 months
    • Actionable alterations determined by FoundationOne assay
  • For Groups 1 or 2, treatment naïve for newly diagnosed malignancies; patients must not have been treated with anti-tumor agents.
  • For Group 3, ≥1 prior unmatched systemic therapy regimens (no prior matched therapy is permitted as immediately prior therapy). Patients must be off other anti-tumor agents for at least 5 half-lives of the agent or 4 weeks from the last day of treatment, whichever is shorter.
  • Patients must have measurable disease for solid tumors.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1.
  • New York Hearth Association (NYHA) Functional Classification I - II.
  • Adequate organ and marrow function.

EXCLUSION CRITERIA:

  • Disagreement of two oncologists on prognosis or resectability.
  • Severe or uncontrolled medical disorder that would, in the investigator's opinion, confound study analyses of treatment response.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534675


Contacts
Contact: Hailey Tipton 858-822-0201 htipton@ucsd.edu
Contact: Michael Scur 858-246-0682 mscur@ucsd.edu

Locations
United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Foundation Medicine
Investigators
Principal Investigator: Jason Sicklick, MD and Razelle Kurzrock, MD University of California, San Diego
More Information
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Responsible Party: Jason K. Sicklick, M.D., Assistant Professor, Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02534675     History of Changes
Other Study ID Numbers: 141758
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016