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Clinical Pre-screening Protocol for Ovarian Cancer

A

Allarity Therapeutics

Status

Enrolling

Conditions

Ovarian Cancer

Treatments

Device: Drug Response Predictor® (DRP)

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03877796
2X-1000

Details and patient eligibility

About

The patient's local archival tumor tissue (FFPE) from original tumor, or from the metastatic tissue, will be collected to potentially identify if they - at a later stage of their disease - will be likely to benefit from treatment with any of the investigational cancer drugs available to Allarity Therapeutics. Data from this study can further be used to explore in a retrospective fashion, sensitivity to other chemotherapeutic drugs previously used in the treatment of their ovarian cancer, to investigate whether or not the DRP® method can predict and confirm the obtained sensitivity to the prior given drugs as well as prospective analyses guiding the Investigators on future treatments.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with histological confirmed epithelia ovarian cancer
  • Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.
  • Patients have received no more than one prior line of therapy in the platinum resistant or platinum ineligible setting
  • FFPE tumor tissue available

Exclusion criteria

  • Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.
  • Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator

Trial design

60 participants in 1 patient group

Ovarian cancer patients
Description:
with formalin-fixed paraffin-embedded (FFPE) tumor tissue available
Treatment:
Device: Drug Response Predictor® (DRP)

Trial contacts and locations

5

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Central trial contact

US: Kathleen Moore; Europe: Rebecca Kristeleit

Data sourced from clinicaltrials.gov

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