Clinical Pre-screening Protocol for Ovarian Cancer

Overview

The pre-screening study is established to pre-screen tumor samples from ovarian cancer patients to identify if they, at a later stage of their disease, will benefit from treatment with any investigational cancer drugs available to Oncology Venture, when these drugs are approved for future clinical studies by local authorities.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: September 2021

Interventions

  • Device: Drug Response Predictor┬« (DRP)
    • A DRP is an assay that based on samples from a tumor can predict whether the tumor will respond to a specific drug or not.

Arms, Groups and Cohorts

  • Ovarian cancer patients
    • with formalin-fixed paraffin-embedded (FFPE) tumor tissue available

Clinical Trial Outcome Measures

Primary Measures

  • Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug
    • Time Frame: up to 2 years
    • based on FFPE ovarian cancer tissue

Secondary Measures

  • Retrospective analysis of whether or not the DRP method can predict and confirm the obtained sensitivity to the prior drugs used in the treatment of ovarian cancer
    • Time Frame: up to 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with histological confirmed epithelia ovarian cancer
  • Relapse after 2 or more chemotherapies for ovarian cancer
  • FFPE tumor tissue available

Exclusion Criteria

  • Other primary malignancy within the last 5 years prior to enrolment

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oncology Venture
  • Collaborator
    • Amarex Clinical Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Christin Whalen, MD, +617-582-7738, christin_whalen@DFCI.HARVARD.EDU

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